{"id":881746,"date":"2025-09-03T16:35:50","date_gmt":"2025-09-03T20:35:50","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/avadel-pharmaceuticals-strengthens-sleep-medicine-portfolio-with-exclusive-license-of-valiloxybate-from-xwpharma-ltd\/"},"modified":"2025-09-03T16:35:50","modified_gmt":"2025-09-03T20:35:50","slug":"avadel-pharmaceuticals-strengthens-sleep-medicine-portfolio-with-exclusive-license-of-valiloxybate-from-xwpharma-ltd","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/avadel-pharmaceuticals-strengthens-sleep-medicine-portfolio-with-exclusive-license-of-valiloxybate-from-xwpharma-ltd\/","title":{"rendered":"Avadel Pharmaceuticals Strengthens Sleep Medicine Portfolio with Exclusive License of Valiloxybate from XWPharma Ltd"},"content":{"rendered":"
\n

\n \u2013 Expands Avadel\u2019s pipeline with salt-free, artificial sweetener-free, once-at-bedtime oxybate for treatment of narcolepsy and idiopathic hypersomnia \u2013<\/em>\n <\/p>\n

\n \u2013 Initial pharmacokinetic (PK) and comparative bioavailability study to initiate <\/em>
\n in fourth quarter 2025 with pivotal PK trial planned for second half 2026 <\/em>
\n \u2013<\/em>\n <\/p>\n

\n \u2013 XWPharma to receive $20 million upfront; potential for development, regulatory and sales milestone payments in addition to royalties on future net sales \u2013 <\/em>\n <\/p>\n

DUBLIN and REDWOOD CITY, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, and XWPharma Ltd. (\u201cXWPharma\u201d) together announced today that Avadel has entered into an exclusive global license agreement with XWPharma to develop and commercialize valiloxybate, a GABAB<\/sub> receptor agonist, for all indications, including the treatment of sleep disorders, such as narcolepsy and idiopathic hypersomnia (\u201cIH\u201d). Valiloxybate has been purposefully designed to deliver the therapeutic benefits of oxybate therapy through a once-at-bedtime, salt-free and artificial sweetener-free formulation.<\/p>\n

“The addition of valiloxybate, the only once-at-bedtime, salt-free and artificial sweetener-free, extended-release oxybate, into our portfolio further reflects Avadel\u2019s position as a leader in sleep medicine,\u201d said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. \u201cThe broad adoption of LUMRYZ demonstrates the transformative benefits that a once-at-bedtime oxybate therapy can bring to patients and their families. As an innovator in the treatment of sleep disorders, we are excited to add valiloxybate to our pipeline.\u201d<\/p>\n

\u201cWe are pleased to enter into this licensing agreement with Avadel, a recognized leader in the clinical and commercial advancement of once-at-bedtime oxybate therapy and the ideal partner to progress valiloxybate to market,\u201d said James Huang, Executive Chairman of XWPharma. \u201cWe are excited for the opportunity to offer access to this innovative therapy to a broad population of those living with sleep disorders.\u201d<\/p>\n

\u201cI am thrilled that Avadel is continuing to advance its mission to improve the lives of those living with hypersomnolence disorders by building on the team\u2019s expertise in innovation and novel drug delivery system development,\u201d said Anne Marie Morse, D.O., Director of Pediatric Neurology at\u00a0Geisinger Medical Center\u00a0at Janet Weis Children\u2019s Hospital. \u201cThe plans to develop valiloxybate for the treatment of narcolepsy and IH with a once at nighttime medication delivery system grows our ability to reach and personalize care for more individuals living with these conditions.\u201d<\/p>\n

\u201cOxybates are transformational medications for people living with narcolepsy and IH, as they provide proven durable efficacy and address the 24 hour a day nature of these disorders. While sodium sensitivity can affect a small proportion of these patients, all patients deserve the benefit of personalized care and the option of a no sodium once at bedtime dosing solution. I believe the additional option of once at bedtime no sodium valiloxybate will further expand utilization and, most importantly, benefit more patients,\u201d continued Dr. Morse.<\/p>\n

\n About the Licensing Agreement <\/strong>\n <\/p>\n

Under the terms of the agreement, XWPharma grants Avadel an exclusive global license to develop, manufacture and commercialize valiloxybate worldwide, excluding mainland China, Hong Kong, and Macau. XWPharma will receive an upfront payment of $20 million from Avadel and is eligible to receive milestone payments associated with certain development milestones of up to $30 million. Avadel has also agreed to pay XWPharma up to an aggregate of $155 million in performance-based tiered sales milestones for first achievement of annual net sales up to $750 million. For first achievement of annual net sales exceeding $750 million and up to $3.5 billion, Avadel will pay XWPharma certain performance-based sales milestone payments equal to 10% of each of those sales milestones. In addition, Avadel has agreed to pay tiered royalties ranging from high-single digit to mid-teens, as a percentage of net sales of the licensed products, and also an additional $10 million milestone payment after the first commercial sale in the U.S. for each indication beyond narcolepsy and IH following FDA approval for same.<\/p>\n

Avadel expects to advance its valiloxybate formulation into an initial PK study in the fourth quarter of 2025, followed by a pivotal PK trial in the second half of 2026. The program is expected to benefit from Avadel\u2019s existing infrastructure and commercial capabilities, potentially allowing for efficient clinical and regulatory advancement via a bioequivalence pathway as well as a streamlined commercial launch, if approved.<\/p>\n

\n About Valiloxybate<\/strong>\n <\/p>\n

Valiloxybate is a GABAB<\/sub> receptor agonist, designed to deliver the therapeutic benefits of oxybate therapy through a once-at-bedtime, salt-free and artificial sweetener-free formulation. The molecule\u2019s properties enable extended-release delivery, offering a potentially differentiated profile from traditional oxybate therapies. Importantly, preliminary clinical data suggest the potential for bioequivalence to be established between valiloxybate and Avadel\u2019s LUMRYZ, the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. Accordingly, successful completion of the PK clinical program and FDA alignment with our regulatory approach could potentially result in a streamlined and capital-efficient development pathway for valiloxybate.<\/p>\n

\n About LUMRYZ\u2122 (sodium oxybate) for extended-release oral suspension<\/strong>\n <\/p>\n

LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients seven years of age and older with narcolepsy.<\/p>\n

The FDA approval of LUMRYZ was supported by results from REST-ON\u2122, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians\u2019 overall assessment of patients\u2019 functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.<\/p>\n

With its approvals in May 2023 and October 2024, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients seven years of age and older with narcolepsy respectively due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.<\/p>\n

LUMRYZ is only currently approved for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy, and Avadel does not sell LUMRYZ for any indication beyond narcolepsy.<\/p>\n

\n INDICATIONS<\/strong>
\n
LUMRYZ\u00a0(sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients seven years of age and older with narcolepsy:<\/p>\n