{"id":827404,"date":"2025-03-19T07:47:55","date_gmt":"2025-03-19T11:47:55","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/"},"modified":"2025-03-19T07:47:55","modified_gmt":"2025-03-19T11:47:55","slug":"jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/","title":{"rendered":"Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex\u00ae (cannabidiol) at American Academy of Neurology Annual Meeting"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p class=\"prntac\">\n        <i>Updated top-line results demonstrate improved outcomes in adults with narcolepsy or idiopathic\u00a0hypersomnia treated with Xywav as observed in the Phase 4 DUET (Developing Understanding of Hypersomnia by Evaluating Low-Sodium Oxybate Treatment) study<\/i>\n      <\/p>\n<p class=\"prntac\">\n        <i>Novel analysis of real-world\u00a0Epidiolex treatment patterns underscore importance of dose optimization for improved patient persistence<\/i>\n      <\/p>\n<p>\n        <i>For U.S. media and investors only<\/i>\n      <\/p>\n<p>\n        <span class=\"legendSpanClass\"><br \/>\n          <span class=\"xn-location\">DUBLIN<\/span><br \/>\n        <\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">March 19, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Jazz Pharmaceuticals plc\u00a0(Nasdaq: JAZZ)\u00a0today\u00a0announced that seven abstracts from across its neuroscience portfolio will be featured\u00a0at\u00a0the\u00a077<sup>th<\/sup> Annual\u00a0American Academy\u00a0of\u00a0Neurology\u00a0Meeting (AAN) being held <span class=\"xn-chron\">April 5-9, 2025<\/span>, in <span class=\"xn-location\">San Diego<\/span>.<\/p>\n<p>Data presented at the meeting includes an updated presentation of top-line results of the open-label, single-arm, Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, evaluating the effectiveness and safety of low-sodium oxybate, Xywav<sup>\u00ae<\/sup> (calcium, magnesium, potassium, and sodium oxybates) oral solution, on key sleep outcomes and daytime symptoms, including excessive daytime sleepiness (EDS), in adults with narcolepsy or idiopathic hypersomnia (IH). Notably, the results from DUET demonstrated statistically significant improvements from baseline to end of treatment in Epworth Sleepiness Scale (ESS) scores, reduced sleep stage shifts, increased deep sleep and reduced number of awakenings among adults with narcolepsy treated with <i>Xywav<\/i>. In adults with IH, <i>Xywav <\/i>treatment also showed improvements in ESS and Idiopathic Hypersomnia Severity Scale scores. Further, new patient-reported data from DUET demonstrated the association of <i>Xywav<\/i> treatment with improvements in daytime symptoms and functional impacts, including cognitive complaints, among adults with narcolepsy or IH. <i>Xywav<\/i> is indicated for the treatment of EDS or cataplexy in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia.<\/p>\n<p>&#8220;This year&#8217;s presentations at the AAN Annual Meeting reinforce our ongoing commitment to addressing debilitating neurological disorders, with limited or no treatment options including narcolepsy, idiopathic hypersomnia and epilepsy,&#8221; said <span class=\"xn-person\">Sarah Akerman<\/span>, MD, head of neuroscience global medical and scientific affairs of Jazz Pharmaceuticals. &#8220;We continually strive to expand our understanding, research and capabilities in neuroscience through ongoing data generation for <i>Xywav<\/i> and <i>Epidiolex<\/i> to ensure patients&#8217; lived experiences and needs are reflected holistically. By listening to our patients, their care teams and leading industry experts, we aim to better address the unmet needs of those living with these difficult-to-treat conditions and ultimately help redefine possibilities for their lives.&#8221;<\/p>\n<p>Highlights at the 2025 AAN Annual Meeting\u00a0include:<\/p>\n<ul type=\"disc\">\n<li>Two presentations showcasing updated results from the open-label, single-arm, Phase 4 DUET trial of adults with narcolepsy or\u00a0IH, which evaluated the effectiveness and safety of <i>Xywav<\/i> on key sleep outcomes, daytime symptoms, and functional impacts, including cognitive complaints, work productivity, and daily activities.<\/li>\n<li>Novel analysis of real-world\u00a0Epidiolex<i><sup>\u00ae<\/sup><\/i>\u00a0(cannabidiol) treatment patterns from U.S. specialty pharmacy data found the overall probability of persistence at one year was nearly 70% (69.9%) among new patients and underscores the importance of dose optimization. The analysis shows how healthcare providers optimize dosing over time, with half (52%) of patients taking dosages &gt;15 mg\/kg\/day at 12 months and those taking an average of &gt;20 mg\/kg\/day having the lowest likelihood of discontinuation. This real-world data demonstrates the importance of dose optimization for long-term persistence, which could lead to improved seizure control and tolerability.<\/li>\n<\/ul>\n<p>The\u00a02025\u00a0AAN Annual Meeting\u00a0abstracts\u00a0are\u00a0available\u00a0online\u00a0at <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4385714-1&amp;h=782802717&amp;u=https%3A%2F%2Findex.mirasmart.com%2FAAN2025%2F&amp;a=index.mirasmart.com%2FAAN2025\" target=\"_blank\" rel=\"nofollow\">index.mirasmart.com\/AAN2025<\/a>.<\/p>\n<p>A\u00a0full\u00a0list\u00a0of\u00a0Jazz Pharmaceuticals&#8217;\u00a0presentations\u00a0follows below:<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tr>\n<td class=\"prnpr2 prnpl2 prnvat prncbts prnbrbrs prnbbbs prnbsbls\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\"><br \/>\n                  <b>Presentation\u00a0Title<\/b><br \/>\n                <\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\"><br \/>\n                  <b>Lead <\/b><br \/>\n                  <b>Author<\/b><br \/>\n                <\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\"><br \/>\n                  <b>Poster Number \/ Session Title \/ <br \/>Date &amp; Time (PT)<\/b><br \/>\n                <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"3\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\"><br \/>\n                  <b>Xywav Data<\/b><br \/>\n                <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Self-Reported Cognitive Complaints and Work<br \/>Productivity in Participants With Narcolepsy<br \/>After Low-Sodium Oxybate treatment: Results<br \/>From the Phase 4 DUET Study<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">LD<br \/>Schneider<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Poster #: 002<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session: P8 Sleep 2<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session Date\/Time: Tuesday, April 8, <br \/>8:00 AM \u2013 9:00 AM <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Effectiveness and Safety of Low-Sodium<br \/>Oxybate in Participants With Narcolepsy:<br \/>Top-line Results From the Phase 4 DUET<br \/>Study<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">LD<br \/>Schneider<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Poster #: 008<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session: P10: General Neurology: New,<br \/>Potential, and Innovative Treatments 2<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session Date\/Time: Tuesday, April 8,<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">5:00 PM \u2013 6:00 PM <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Efficacy and Safety of Low-Sodium Oxybate in<br \/>Narcolepsy Patients With\/Without<br \/>Psychiatric\/Neurologic Comorbidities<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">C Chepke<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Poster #: 004<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session: P12 General Neurology Posters 5<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session Date\/Time: Wednesday, April 9, 11:45 AM \u2013 12:45 PM <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"3\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml6\">\n                <span class=\"prnews_span\"><br \/>\n                  <b>Epidiolex\u00a0Data<\/b><br \/>\n                <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Dosing Patterns and Persistence on<br \/>Cannabidiol (CBD) \u2013 Insights From US<br \/>Specialty Pharmacy Data<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">G Pohl<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Poster #: 005<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session: P12: Epilepsy\/Clinical<br \/>Neurophysiology (EEG): Retrospective<br \/>Studies, Reviews, and Meta-analyses in<br \/>Epilepsy<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session Date\/Time: Wednesday, April 9, 11:45 AM \u2013 12:45 PM <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Tuberous Sclerosis Complex (TSC)\u2013<br \/>Associated Neuropsychiatric Disorder (TAND)<br \/>Outcomes Following Add-on Cannabidiol<br \/>(CBD) Treatment: 3-Month Analysis of Open-<br \/>Label Phase 3b\/4 Trial EpiCom\u00a0<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">A van Eeghen<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Poster #: 005<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session: P8: Epilepsy\/Clinical<br \/>Neurophysiology (EEG): Anti-seizure<br \/>Medications: Clinical Trials<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session Date\/Time: Tuesday, April 8,<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">8:00 AM \u2013 9:00 AM <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Caregiver-Reported Real-World Use of<br \/>Cannabidiol (CBD) and Effects on Seizures<br \/>and Caregiver Burden: Results From the<br \/>CARE-EpiC Survey\u00a0<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">S Thomas<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Poster #: 003<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session: P1: Epilepsy\/Clinical<br \/>Neurophysiology (EEG): Special<br \/>Populations: Women with Epilepsy,<br \/>Caregivers, Adolescents, and Elderly<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session Date\/Time: Saturday, April 5, 11:45 AM \u2013 12:45 PM <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Nurse-Reported Outcomes of Cannabidiol<br \/>(CBD) Treatment in the Long-Term Care<br \/>(LTC) Setting: Results From the BECOME-<br \/>LTC Survey<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">N Wrobel<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Poster #: 016 <\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session: P2: Epilepsy\/Clinical<br \/>Neurophysiology (EEG): Clinical Outcomes<br \/>in Epilepsy<\/span>\n              <\/p>\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Session Date\/Time: Sunday, April 6, <br \/>8:00 AM \u2013 9:00 AM PT<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n<p>\n        <b>About Xywav<sup>\u00ae<\/sup>\u00a0(calcium, magnesium, potassium, and sodium oxybates) oral solution<\/b><br \/>\n        <br \/>\n        <i>Xywav<\/i>\u00a0is the only low-sodium oxybate approved by the\u00a0U.S. Food and Drug Administration\u00a0(FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for\u00a0<i>Xywav<\/i>\u00a0for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for\u00a0<i>Xywav<\/i>\u00a0for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem<sup>\u00ae<\/sup>\u00a0(sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that\u00a0<i>Xywav<\/i>\u00a0provides a greatly reduced chronic sodium burden compared to\u00a0<i>Xyrem<\/i>.\u00a0<i>Xywav\u00a0<\/i>has 131 mg of sodium at the maximum recommended nightly dose\u00a0whereas other high sodium oxybates have 1640 mg at the equivalent dose.\u00a0<i>Xywav<\/i>\u00a0is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg\/night at the recommended dose range of 6 g to 9 g\/night.\u00a0<i>Xywav<\/i>\u00a0is the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake.<\/p>\n<p>\n        <i>Xywav\u00a0<\/i>is also the first and only\u00a0U.S.\u00a0FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for\u00a0<i>Xywav<\/i>\u00a0for the treatment of idiopathic hypersomnia in adults.\u00a0<i>Xywav<\/i>\u00a0is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as EDS, sleep inertia (severe grogginess or confusion when waking up), long sleep duration and cognitive impairment.\u00a0<i>Xywav<\/i>\u00a0can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.<\/p>\n<p>The exact mechanism of action of\u00a0<i>Xywav<\/i>\u00a0in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of\u00a0<i>Xywav<\/i>\u00a0are mediated through GABA<sub>B<\/sub>\u00a0actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.<sup>1<\/sup>\u00a0The\u00a0U.S.\u00a0Drug Enforcement Agency\u00a0(DEA) has designated\u00a0<i>Xywav\u00a0<\/i>as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.<sup>1,2\u00a0<\/sup>Because of the risks of central nervous system (CNS) depression and abuse and misuse,\u00a0<i>Xywav<\/i>\u00a0is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.<\/p>\n<p>\n        <b>Important Safety Information for Xywav<\/b>\n      <\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prncbts prnbrbrs prnbbbs prnbsbls\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml50\">\n                <span class=\"prnews_span\"><br \/>\n                  <b>WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE.<\/b><br \/>\n                <\/span>\n              <\/p>\n<ul type=\"disc\">\n<li class=\"prnews_li\">\n                  <b><br \/>\n                    <u>Central Nervous System Depression<\/u><br \/>\n                  <\/b><br \/>\n                  <br \/>\n                  <b>XYWAV is a CNS depressant. Clinically significant respiratory depression and<br \/>obtundation may occur in patients treated with XYWAV at recommended doses. Many<br \/>patients who received XYWAV during clinical trials in narcolepsy and idiopathic<br \/><\/b><br \/>\n                  <b>hypersomnia were receiving CNS stimulants.<\/p>\n<p><\/b>\n                <\/li>\n<li class=\"prnews_li\">\n                  <b><br \/>\n                    <u>Abuse and Misuse<\/u><br \/>\n                  <\/b><br \/>\n                  <br \/>\n                  <b>The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or<br \/>misuse of illicit GHB, either alone or in combination with other CNS depressants, is<br \/>associated with CNS adverse reactions, including seizure, respiratory depression,<br \/>decreases in the level of consciousness, coma, and death.<\/b>\n                <\/li>\n<\/ul>\n<p class=\"prnml6\">\n                <span class=\"prnews_span\"><br \/>\n                  <b>Because of the risks of CNS depression and abuse and misuse, XYWAV is available only<br \/>through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the<br \/>XYWAV and XYREM REMS.<\/b><br \/>\n                <\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n<p>\n        <b><br \/>\n          <u>Contraindications<br \/><\/u><br \/>\n        <\/b>XYWAV\u00a0is\u00a0contraindicated<\/p>\n<ul type=\"disc\">\n<li>in combination with sedative hypnotics or alcohol and<\/li>\n<li>in patients with\u00a0succinic\u00a0semialdehyde\u00a0dehydrogenase\u00a0deficiency.<\/li>\n<\/ul>\n<p>\n        <b><br \/>\n          <u>Warnings and Precautions<br \/><\/u><br \/>\n        <\/b><br \/>\n        <b>Central Nervous System Depression<\/b>\n      <\/p>\n<p>The concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and\/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYWAV should be considered.<\/p>\n<p>After\u00a0first initiating treatment\u00a0and until certain that\u00a0XYWAV\u00a0does not affect\u00a0them\u00a0adversely (eg, impair\u00a0judgment, thinking,\u00a0or motor skills), caution\u00a0patients against\u00a0hazardous\u00a0activities\u00a0requiring complete\u00a0mental alertness\u00a0or motor\u00a0coordination\u00a0such as operating\u00a0hazardous\u00a0machinery, including\u00a0automobiles\u00a0or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking\u00a0XYWAV. Patients\u00a0should be queried\u00a0about CNS depression-related events\u00a0upon initiation\u00a0of XYWAV\u00a0therapy\u00a0and\u00a0periodically\u00a0thereafter.<\/p>\n<p>\n        <b>Abuse and Misuse<br \/><\/b>XYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known as\u00a0gamma-hydroxybutyrate (GHB), a Schedule\u00a0I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of\u00a0GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.<\/p>\n<p>\n        <b>XYWAV<\/b>\u00a0<b>and<\/b>\u00a0<b>XYREM<\/b>\u00a0<b>REMS<br \/><\/b>Because of the risks of central nervous system depression and abuse and misuse,\u00a0XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS.<\/p>\n<p>Notable\u00a0requirements\u00a0of\u00a0the\u00a0XYWAV\u00a0and\u00a0XYREM\u00a0REMS\u00a0include the\u00a0following:<\/p>\n<ul type=\"disc\">\n<li>Healthcare Providers who prescribe\u00a0XYWAV\u00a0are\u00a0specially certified<\/li>\n<li>XYWAV\u00a0will\u00a0be\u00a0dispensed\u00a0only\u00a0by\u00a0the\u00a0central\u00a0pharmacy that\u00a0is\u00a0specially\u00a0certified<\/li>\n<li>XYWAV\u00a0will be dispensed\u00a0and shipped\u00a0only to patients\u00a0who are enrolled in the XYWAV and\u00a0XYREM\u00a0REMS\u00a0with\u00a0documentation\u00a0of\u00a0safe\u00a0use<\/li>\n<\/ul>\n<p>Further\u00a0information\u00a0is available\u00a0at\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4385714-1&amp;h=9260591&amp;u=https%3A%2F%2Fwww.xywavxyremrems.com%2F&amp;a=www.XYWAVXYREMREMS.com\" target=\"_blank\" rel=\"nofollow\">www.XYWAVXYREMREMS.com<\/a>\u00a0or\u00a01-866-997-3688.<\/p>\n<p>\n        <b>Respiratory Depression and Sleep-Disordered Breathing<br \/><\/b>XYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In\u00a0overdoses\u00a0of oxybate\u00a0and\u00a0with illicit\u00a0use of GHB, life-threatening respiratory depression\u00a0has been\u00a0reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and\u00a0pediatric\u00a0patients. A significant increase\u00a0in the\u00a0number\u00a0of central apneas\u00a0and clinically significant\u00a0oxygen\u00a0desaturation\u00a0may occur\u00a0in patients with obstructive\u00a0sleep apnea\u00a0treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy.<\/p>\n<p>\n        <b>Depression and\u00a0Suicidality<\/b><br \/>\n        <br \/>In Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depression\u00a0and depressed mood were reported in 3% and 4%, respectively,\u00a0of patients treated with XYWAV. Two patients\u00a0(1%)\u00a0discontinued\u00a0XYWAV because\u00a0of depression. In most cases, no change in XYWAV treatment was required.\u00a0<\/p>\n<p>In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment.<\/p>\n<p>Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders. The emergence\u00a0of\u00a0depression\u00a0in patients treated\u00a0with XYWAV requires careful and immediate\u00a0evaluation. Monitor patients for the emergence of increased\u00a0depressive\u00a0symptoms and\/or suicidality\u00a0while\u00a0taking\u00a0XYWAV.<\/p>\n<p>\n        <b>Other Behavioral or Psychiatric Adverse Reactions<\/b><br \/>\n        <br \/>In\u00a0Study 1,\u00a0confusion and anxiety\u00a0occurred\u00a0in\u00a01% and 5% of\u00a0patients with narcolepsy\u00a0treated\u00a0with XYWAV, respectively. One patient\u00a0experienced\u00a0visual\u00a0hallucinations and confusion\u00a0after\u00a0ingesting approximately\u00a09\u00a0grams\u00a0of XYWAV.<\/p>\n<p>In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively.\u00a0One patient experienced visual hallucinations, which led to discontinuation of XYWAV.\u00a0<\/p>\n<p>Other\u00a0neuropsychiatric\u00a0reactions reported\u00a0with oxybate\u00a0(same\u00a0active\u00a0moiety as XYWAV)\u00a0in adult or pediatric clinical\u00a0trials\u00a0and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should\u00a0be\u00a0carefully monitored.<\/p>\n<p>\n        <b>Parasomnias<br \/><\/b>Parasomnias\u00a0can\u00a0occur\u00a0in\u00a0patients\u00a0taking\u00a0XYWAV.<\/p>\n<p>In Study 1 and Study 2,\u00a0parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated with\u00a0XYWAV, respectively.\u00a0<\/p>\n<p>In\u00a0a\u00a0clinical trial\u00a0of\u00a0XYREM\u00a0(same\u00a0active moiety\u00a0as\u00a0XYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate\u00a0(same\u00a0active\u00a0moiety\u00a0as\u00a0XYWAV) and\u00a0in\u00a0postmarketing\u00a0experience\u00a0with\u00a0sodium\u00a0oxybate.<\/p>\n<p>Episodes\u00a0of\u00a0sleepwalking\u00a0should\u00a0be\u00a0fully\u00a0evaluated\u00a0and\u00a0appropriate\u00a0interventions\u00a0considered.<\/p>\n<p>\n        <b><br \/>\n          <u>Most Common Adverse Reactions<br \/><\/u><br \/>\n        <\/b>The\u00a0most\u00a0common adverse\u00a0reactions (occurring in \u22655% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache,\u00a0dizziness, anxiety, insomnia, decreased appetite,\u00a0hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.\u00a0<\/p>\n<p>In\u00a0the\u00a0pediatric clinical\u00a0trial\u00a0with\u00a0XYREM\u00a0(same\u00a0active\u00a0moiety\u00a0as\u00a0XYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (\u22655%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). The overall adverse reaction profile of\u00a0XYREM in the pediatric\u00a0clinical trial was similar to that seen in the adult clinical trial\u00a0program. The safety profile in pediatric patients\u00a0with XYWAV is expected\u00a0to be similar\u00a0to that\u00a0of adult\u00a0patients treated\u00a0with XYWAV and to that of pediatric patients treated with XYREM.<\/p>\n<p>\n        <b><br \/>\n          <u>Additional Adverse Reactions<br \/><\/u><br \/>\n        <\/b>Adverse reactions that occurred in\u00a02-&lt;5% of adult patients treated with XYWAV in the Open\u00ad Label Titration and Stable Dose Periods of the randomized-withdrawal study in adult patients with narcolepsy with cataplexy (Study 1) were fatigue, dry mouth, depressed mood, enuresis, irritability, paresthesia, depression, tremor, somnolence, and muscle spasms. Adverse reactions occurring in 2-&lt;5% of patients treated with\u00a0XYWAV in the IH study include balance disorder, muscle spasms, fall, paresthesia,\u00a0snoring, weight decreased, bruxism, confusional state, depressed mood, feeling drunk, and irritability.<\/p>\n<p>Adverse reactions that occurred in\u00a0\u22652% of patients in clinical studies with oxybate (but not in\u00a0Study\u00a01)\u00a0and\u00a0which\u00a0may\u00a0be\u00a0relevant for\u00a0XYWAV,\u00a0were\u00a0pain,\u00a0feeling drunk,\u00a0pain\u00a0in\u00a0extremity,\u00a0cataplexy, disturbance\u00a0in\u00a0attention,\u00a0sleep\u00a0paralysis,\u00a0and\u00a0disorientation.<\/p>\n<p>Discontinuation: In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%). In Study 2, 17 of 154 (11%) patients across all study periods (excluding placebo during the DB\u00a0RWP) (up to 42\u00a0weeks) reported adverse reactions that led to withdrawal from the study (anxiety, nausea, insomnia, vomiting, fatigue, feeling abnormal, fall, decreased appetite, dizziness, paresthesia, tremor, parasomnia, confusional state, hallucination visual, and irritability). The most common adverse reaction leading to discontinuation was anxiety (3.2%). In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment.<\/p>\n<p>In the pediatric clinical trial with XYREM (same active moiety as XYWAV), 7 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache).<\/p>\n<p>\n        <b><br \/>\n          <u>Drug Interactions<br \/><\/u><br \/>\n        <\/b>XYWAV is contraindicated in combination with alcohol or sedative hypnotics. Use of other CNS depressants\u00a0may\u00a0potentiate\u00a0the\u00a0CNS-depressant\u00a0effects of\u00a0XYWAV.<\/p>\n<p>Concomitant\u00a0use of sodium\u00a0oxybate with divalproex\u00a0sodium\u00a0results in an increase in systemic\u00a0exposure to\u00a0GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study. A similar increase in exposure is expected with concomitant use of\u00a0XYWAV and divalproex\u00a0sodium; therefore, an initial dose reduction of XYWAV is recommended when used concomitantly with\u00a0divalproex\u00a0sodium. Prescribers\u00a0are advised\u00a0to monitor\u00a0patient\u00a0response closely and adjust dose accordingly\u00a0if\u00a0concomitant\u00a0use\u00a0of\u00a0XYWAV\u00a0and\u00a0divalproex\u00a0sodium\u00a0is\u00a0warranted.<\/p>\n<p>\n        <b><br \/>\n          <u>Pregnancy and Lactation<br \/><\/u><br \/>\n        <\/b>There are no adequate data on the developmental risk associated with the use of XYWAV or sodium\u00a0oxybate\u00a0in pregnant women. XYWAV should be used during pregnancy\u00a0only if the potential benefit\u00a0justifies\u00a0the\u00a0potential\u00a0risk\u00a0to\u00a0the\u00a0fetus.\u00a0GHB is excreted in human milk after oral administration of sodium\u00a0oxybate.\u00a0There is insufficient\u00a0information\u00a0on the risk to a breastfed infant, and there is insufficient\u00a0information\u00a0on milk\u00a0production\u00a0in nursing\u00a0mothers.\u00a0The\u00a0developmental\u00a0and\u00a0health\u00a0benefits of\u00a0breastfeeding should be\u00a0considered along with the mother&#8217;s clinical need for XYWAV and any potential adverse effects on the breastfed infant\u00a0from XYWAV\u00a0or\u00a0from\u00a0the\u00a0underlying maternal\u00a0condition.<\/p>\n<p>\n        <b><br \/>\n          <u>Pediatric Use<br \/><\/u><br \/>\n        <\/b>The\u00a0safety and\u00a0effectiveness\u00a0of\u00a0XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV\u00a0has not been studied in a pediatric clinical trial for narcolepsy or\u00a0IH. Use of\u00a0XYWAV in\u00a0pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and\u00a0well\u00adcontrolled\u00a0study\u00a0of\u00a0sodium\u00a0oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar\u00a0to\u00a0that\u00a0observed\u00a0with\u00a0sodium\u00a0oxybate,\u00a0pharmacokinetic data\u00a0of sodium oxybate from adult and pediatric patients, and pharmacokinetic data\u00a0of XYWAV\u00a0from\u00a0healthy\u00a0adult\u00a0volunteers.<\/p>\n<p>Safety\u00a0and\u00a0effectiveness\u00a0of\u00a0XYWAV\u00a0in\u00a0pediatric\u00a0patients below\u00a0the\u00a0age\u00a0of\u00a07\u00a0years\u00a0with narcolepsy have\u00a0not\u00a0been\u00a0established.<\/p>\n<p>Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established.<\/p>\n<p>\n        <b><br \/>\n          <u>Geriatric Use<br \/><\/u><br \/>\n        <\/b>In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the\u00a0dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of\u00a0concomitant\u00a0disease or\u00a0other\u00a0drug\u00a0therapy.<\/p>\n<p>\n        <b><br \/>\n          <u>Hepatic Impairment<br \/><\/u><br \/>\n        <\/b>The\u00a0starting\u00a0dose\u00a0of\u00a0XYWAV\u00a0should\u00a0be\u00a0reduced\u00a0in\u00a0patients\u00a0with\u00a0liver\u00a0impairment.<\/p>\n<p>\n        <b>Dosage Modification in Patients with Hepatic Impairment:\u00a0<\/b>The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses.<\/p>\n<p>\n        <b><br \/>\n          <u>Dependence and Tolerance<br \/><\/u><br \/>\n        <\/b>There\u00a0have\u00a0been\u00a0case\u00a0reports\u00a0of\u00a0withdrawal,\u00a0ranging\u00a0from\u00a0mild\u00a0to\u00a0severe,\u00a0following\u00a0discontinuation\u00a0of\u00a0illicit use of GHB\u00a0at frequent\u00a0repeated\u00a0doses\u00a0(18\u00a0g to 250 g per day)\u00a0in excess\u00a0of the recommended\u00a0dosage range. Signs and symptoms\u00a0of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required.<\/p>\n<p>In the clinical trial experience\u00a0with\u00a0XYREM in narcolepsy\/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the\u00a0XYWAV clinical trial in adult narcolepsy\/cataplexy patients at recommended doses,\u00a0one patient\u00a0reported insomnia\u00a0following\u00a0abrupt\u00a0discontinuation\u00a0of\u00a0XYWAV. In the XYWAV clinical trial in adult idiopathic hypersomnia patients at recommended doses, six patients reported insomnia, two patients reported early insomnia, and one patient reported visual and auditory hallucinations following abrupt discontinuation of XYWAV<i>.<\/i><\/p>\n<p>Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been\u00a0some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the\u00a0recommended\u00a0XYWAV\u00a0dosage\u00a0regimen.<\/p>\n<p>\n        <b>About Epidiolex<sup>\u00ae<\/sup>\/Epidyolex<sup>\u00ae<\/sup> (cannabidiol)\u00a0<br \/><\/b><br \/>\n        <i>Epidiolex\/Epidyolex <\/i>is a prescription, plant-derived cannabis-based medicine administered as an oral solution which contains highly purified cannabidiol (CBD). Cannabidiol, the active ingredient in <i>Epidiolex<\/i>, is a cannabinoid that naturally occurs in the <i>Cannabis sativa <\/i>L. plant. The precise mechanisms by which <i>Epidiolex <\/i>exerts its anticonvulsant effect in humans are unknown<i>. Epidiolex <\/i>was approved by the U.S. Food and Drug Administration (FDA) for use in the U.S., the European Commission (EC) for use in <span class=\"xn-location\">Europe<\/span>, the Medicines and Healthcare products Regulatory Agency (MHRA) for use in <span class=\"xn-location\">Great Britain<\/span>, the Therapeutic Goods Administration for use in <span class=\"xn-location\">Australia<\/span>, Swissmedic for use in <span class=\"xn-location\">Switzerland<\/span>, the Food &amp; Nutrition Services of the Israel Ministry of Health for use in <span class=\"xn-location\">Israel<\/span>, and the New Zealand Medicines and Medical Devices Safety Authority for use in <span class=\"xn-location\">New Zealand<\/span>, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S., <i>Epidiolex <\/i>is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older. <i>Epidiolex <\/i>has received approval in the European Union under the tradename <i>Epidyolex <\/i>for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and DS in patients two years and older, and for adjunctive use to treat seizures associated with TSC, in patients two years of age and older. <i>Epidiolex <\/i>has received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of seizures associated with LGS, DS, and TSC. Similarly, <i>Epidyolex <\/i>received ODD from the European Medicines Agency (EMA) for the same indications.<\/p>\n<p>\n        <b>Important Safety Information &amp; Indications <\/b>\n      <\/p>\n<p>\n        <b>CONTRAINDICATION: HYPERSENSITIVITY <\/b>\n      <\/p>\n<p>EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product.<\/p>\n<p>\n        <b>WARNINGS &amp; PRECAUTIONS <\/b>\n      <\/p>\n<p>\n        <b>Hepatic Injury:<br \/><\/b>EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Obtain transaminase and bilirubin levels prior to starting treatment, at 1, 3, and 6 months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and\/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury. There have been postmarketing reports of cholestatic or mixed patterns of liver injury. Elevated ammonia levels were reported in some patients with transaminase elevations; most taking concomitant valproate, clobazam, or both. Consider discontinuation or dose adjustment of valproate or clobazam if ammonia is elevated.<\/p>\n<p>\n        <b>Somnolence and Sedation:\u00a0<br \/><\/b>EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants.<\/p>\n<p>\n        <b>Suicidal Behavior and Ideation:\u00a0<br \/><\/b>Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise them to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness.<\/p>\n<p>\n        <b>Withdrawal of Antiepileptic Drugs:\u00a0<br \/><\/b>As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.<\/p>\n<p>\n        <b>ADVERSE REACTIONS:\u00a0<br \/><\/b>The most common adverse reactions in patients receiving EPIDIOLEX (\u226510% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed.<\/p>\n<p>\n        <b>PREGNANCY:\u00a0<br \/><\/b>EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the EPIDIOLEX Pregnancy Surveillance Program and the North American Antiepileptic Drug (NAAED) Pregnancy Registry.<\/p>\n<p>\n        <b>DRUG INTERACTIONS:\u00a0<br \/><\/b>Strong inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates (see full Prescribing Information). Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX. A lower starting dose of everolimus is recommended when added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary.<\/p>\n<p>\n        <b>INDICATIONS:\u00a0<br \/><\/b>EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.<\/p>\n<p>\n        <b>Please read the EPIDIOLEX full Prescribing Information for additional important information <\/b><br \/>\n        <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4385714-1&amp;h=1107189281&amp;u=https%3A%2F%2Fpp.jazzpharma.com%2Fpi%2Fepidiolex.en.USPI.pdf&amp;a=here\" target=\"_blank\" rel=\"nofollow\"><br \/>\n          <b><br \/>\n            <u>here<\/u><br \/>\n          <\/b><br \/>\n        <\/a><br \/>\n        <b>. <\/b>\n      <\/p>\n<p>\n        <b>About Jazz Pharmaceuticals<br \/><\/b>Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases \u2014 often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in\u00a0Dublin, Ireland\u00a0with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4385714-1&amp;h=3974932389&amp;u=http%3A%2F%2Fwww.jazzpharmaceuticals.com%2F&amp;a=www.jazzpharmaceuticals.com\" target=\"_blank\" rel=\"nofollow\">www.jazzpharmaceuticals.com<\/a> for more information.<\/p>\n<p>\n        <b>Contacts:<\/b>\n      <\/p>\n<p>\n        <b>Media:<\/b><br \/>\n        <br \/>\n        <span class=\"xn-person\">Kristin Bhavnani<\/span><br \/>\n        <br \/>Head of Global Corporate Communications<br \/>Jazz Pharmaceuticals plc<br \/><a href=\"mailto:CorporateAffairsMediaInfo@jazzpharma.com\" target=\"_blank\" rel=\"nofollow\">CorporateAffairsMediaInfo@jazzpharma.com<\/a><br \/><span class=\"xn-location\">Ireland<\/span> +353 1 637 2141<br \/>U.S. +1 215 867 4948<\/p>\n<p>\n        <b>Investors:<\/b><br \/>\n        <br \/>\n        <span class=\"xn-person\">Jeff Macdonald<\/span><br \/>\n        <br \/>Executive Director, Investor Relations<br \/>Jazz Pharmaceuticals plc<br \/><a href=\"mailto:InvestorInfo@jazzpharma.com\" target=\"_blank\" rel=\"nofollow\">InvestorInfo@jazzpharma.com<br \/><\/a><span class=\"xn-location\">Ireland<\/span> +353 1 634 3211<br \/>U.S. +1 650 496 2717<\/p>\n<p>\n        <b>References<\/b>:<\/p>\n<ol type=\"1\">\n<li>Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution. Prescribing Information. <span class=\"xn-location\">Palo Alto, CA<\/span>: Jazz Pharmaceuticals, Inc. 2021.<\/li>\n<li>United States Drug Enforcement Agency. Drug Scheduling.\u00a0https:\/\/www.dea.gov\/drug-information\/drug-scheduling. Accessed <span class=\"xn-chron\">March 2025<\/span>.<\/li>\n<\/ol>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder2552\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/272253\/Jazz_Pharmaceuticals_New_Logo.html\" target=\"_blank\" rel=\"nofollow\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/272253\/Jazz_Pharmaceuticals_New_Logo.jpg\" title=\"Jazz Pharmaceuticals Logo (PRNewsFoto\/Jazz Pharmaceuticals plc) (PRNewsFoto\/Jazz Pharmaceuticals plc)\" alt=\"Jazz Pharmaceuticals Logo (PRNewsFoto\/Jazz Pharmaceuticals plc) (PRNewsFoto\/Jazz Pharmaceuticals plc)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder0\"><\/div>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=SF43879&amp;sd=2025-03-19\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-american-academy-of-neurology-annual-meeting-302405085.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-american-academy-of-neurology-annual-meeting-302405085.html<\/a><\/p>\n<p>SOURCE  Jazz Pharmaceuticals plc<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=SF43879&amp;Transmission_Id=202503190730PR_NEWS_USPR_____SF43879&amp;DateId=20250319\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire Updated top-line results demonstrate improved outcomes in adults with narcolepsy or idiopathic\u00a0hypersomnia treated with Xywav as observed in the Phase 4 DUET (Developing Understanding of Hypersomnia by Evaluating Low-Sodium Oxybate Treatment) study Novel analysis of real-world\u00a0Epidiolex treatment patterns underscore importance of dose optimization for improved patient persistence For U.S. media and investors only DUBLIN , March 19, 2025 \/PRNewswire\/ &#8212; Jazz Pharmaceuticals plc\u00a0(Nasdaq: JAZZ)\u00a0today\u00a0announced that seven abstracts from across its neuroscience portfolio will be featured\u00a0at\u00a0the\u00a077th Annual\u00a0American Academy\u00a0of\u00a0Neurology\u00a0Meeting (AAN) being held April 5-9, 2025, in San Diego. Data presented at the meeting includes an updated presentation of top-line results of the open-label, single-arm, Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, evaluating the effectiveness and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex\u00ae (cannabidiol) at American Academy of Neurology Annual Meeting&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-827404","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex\u00ae (cannabidiol) at American Academy of Neurology Annual Meeting - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex\u00ae (cannabidiol) at American Academy of Neurology Annual Meeting - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire Updated top-line results demonstrate improved outcomes in adults with narcolepsy or idiopathic\u00a0hypersomnia treated with Xywav as observed in the Phase 4 DUET (Developing Understanding of Hypersomnia by Evaluating Low-Sodium Oxybate Treatment) study Novel analysis of real-world\u00a0Epidiolex treatment patterns underscore importance of dose optimization for improved patient persistence For U.S. media and investors only DUBLIN , March 19, 2025 \/PRNewswire\/ &#8212; Jazz Pharmaceuticals plc\u00a0(Nasdaq: JAZZ)\u00a0today\u00a0announced that seven abstracts from across its neuroscience portfolio will be featured\u00a0at\u00a0the\u00a077th Annual\u00a0American Academy\u00a0of\u00a0Neurology\u00a0Meeting (AAN) being held April 5-9, 2025, in San Diego. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/","og_locale":"en_US","og_type":"article","og_title":"Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex\u00ae (cannabidiol) at American Academy of Neurology Annual Meeting - Market Newsdesk","og_description":"PR Newswire Updated top-line results demonstrate improved outcomes in adults with narcolepsy or idiopathic\u00a0hypersomnia treated with Xywav as observed in the Phase 4 DUET (Developing Understanding of Hypersomnia by Evaluating Low-Sodium Oxybate Treatment) study Novel analysis of real-world\u00a0Epidiolex treatment patterns underscore importance of dose optimization for improved patient persistence For U.S. media and investors only DUBLIN , March 19, 2025 \/PRNewswire\/ &#8212; Jazz Pharmaceuticals plc\u00a0(Nasdaq: JAZZ)\u00a0today\u00a0announced that seven abstracts from across its neuroscience portfolio will be featured\u00a0at\u00a0the\u00a077th Annual\u00a0American Academy\u00a0of\u00a0Neurology\u00a0Meeting (AAN) being held April 5-9, 2025, in San Diego. Data presented at the meeting includes an updated presentation of top-line results of the open-label, single-arm, Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, evaluating the effectiveness and &hellip; Continue reading \"Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex\u00ae (cannabidiol) at American Academy of Neurology Annual Meeting\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/","og_site_name":"Market Newsdesk","article_published_time":"2025-03-19T11:47:55+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/272253\/Jazz_Pharmaceuticals_New_Logo.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"22 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex\u00ae (cannabidiol) at American Academy of Neurology Annual Meeting","datePublished":"2025-03-19T11:47:55+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/"},"wordCount":4387,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/272253\/Jazz_Pharmaceuticals_New_Logo.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/jazz-pharmaceuticals-to-showcase-research-demonstrating-treatment-benefits-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-and-epidiolex-cannabidiol-at-americ\/","name":"Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav\u00ae (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex\u00ae (cannabidiol) at American Academy of Neurology Annual Meeting - 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