- \n
- CREXONT added to 3 large national formularies: Veterans Administration, UnitedHealthcare and CVS Health<\/i><\/li>\n
- Increases insurance coverage to over 50% of covered lives<\/i><\/li>\n
- CREXONT was approved by the U.S. FDA to treat Parkinson\u2019s disease in 2024<\/i><\/li>\n<\/ul>\n
BRIDGEWATER, N.J.–(BUSINESS WIRE<\/a>)–
\nAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (\u201cAmneal\u201d or the \u201cCompany\u201d), a global biopharmaceutical company, today announced that three large insurance coverage accounts, the Veterans Administration (VA), UnitedHealthcare and CVS Health, have added CREXONT\u00ae<\/sup> (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson\u2019s disease (PD) to their national prescription drug formularies. CREXONT is a prescription medication for the treatment of PD approved by the U.S. FDA in August 2024.\n<\/p>\n\nThis expanded coverage increases CREXONT\u2019s total U.S. insurance coverage from about 30% of covered lives at the end of 2024 to over 50%. The Company had initially set a goal to surpass 50% coverage by the end of 2025, making this milestone\u2014achieved nine months ahead of schedule\u2014a testament to Amneal\u2019s commitment to broadening patient access. The VA has already added the product in its national formulary, covering approximately 10% of U.S. PD patients. UnitedHealthcare will add CREXONT to its standard prescription drug lists in the second quarter of 2025. In addition, CVS Health will add CREXONT as a \u201cpreferred\u201d product to its national formulary on July 1, 2025.\n<\/p>\n
\n\u201cWe are extremely proud to announce the addition of CREXONT on three major insurance platforms,\u201d said Joe Renda, Senior Vice President, Chief Commercial Officer \u2013 Specialty at Amneal Pharmaceuticals. \u201cAchieving over 50% coverage within just six months of launch is a significant milestone, demonstrating the immense value CREXONT offers PD patients and our continued commitment to ensuring patient access.\u201d\n<\/p>\n
CREXONT\u2019s therapeutic benefits include:<\/b><\/p>\n
- \n
- Novel formulation designed to provide long lasting efficacy: <\/b>CREXONT is an innovative formulation of carbidopa\/levodopa (CD\/LD) that combines immediate-release (IR) granules for rapid onset of action and extended-release pellets with a novel technology, designed to target the area of absorption, making CREXONT the longest-lasting oral CD\/LD formulation available today. The novel technology delivers more stable levodopa levels that do not wear off as quickly or as often as traditional IR formulation. Over time with IR CD\/LD therapy, the duration of symptom control may become more unpredictable, and patients may experience more \u201cOff\u201d time. About half of patients taking a PD medication may experience \u201cOff\u201d episodes \u2013 time where their motor symptoms return or are not well-controlled \u2013 within 2 to 3 years of treatment initiation.1<\/sup><\/li>\n
- More \u201cGood On\u201d time with less frequent dosing:<\/b> A head-to-head clinical trial showed CREXONT provides more \u201cGood On\u201d time per day, and 1.55 more hours of \u201cGood On\u201d time per dose (where symptoms are well-controlled without troublesome involuntary movements) compared to IR CD\/LD. This represents a 70% increase in the amount of time each dose helps people feel in control of their PD symptoms.\n<\/li>\n
- Safety profile consistent with IR CD\/LD:<\/b> The most common adverse reactions with CREXONT (incidence \u22653% and greater than IR CD\/LD) are nausea and anxiety. See Important Safety Information below.\n<\/li>\n<\/ul>\n
\nTo further support patients, providers, and care partners as they navigate insurance coverage and their treatment on CREXONT, Amneal offers a full suite of services and support within the Amneal Patient Support Program. For more information, visit https:\/\/crexont.com\/support-resources\/<\/a> or call 1-877-764-9021 Monday-Friday 8:00AM-5:00PM CST for live support.\n<\/p>\n
About CREXONT\u00ae
\n
<\/sup><\/b>CREXONT is an innovative formulation consisting of immediate-release granules with carbidopa and levodopa for rapid onset of action, and extended-release pellets with levodopa for long-lasting efficacy. CREXONT formulation and dosage strengths are different from RYTARY\u00ae<\/sup> (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015. Learn more about CREXONT at crexont.com<\/a>.\n<\/p>\nINDICATION
\n
<\/b>CREXONT (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson\u2019s disease, Parkinson\u2019s disease caused by infection or inflammation of the brain, or Parkinson\u2019s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.\n<\/p>\nIMPORTANT SAFETY INFORMATION<\/b><\/p>\n
- \n
- \nDo not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.\n<\/li>\n
- \nDo not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.\n<\/li>\n
- \nCREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery, until you know how CREXONT affects you.\n<\/li>\n
- \nThe most common side effects that may occur with CREXONT are nausea and anxiety.\n<\/li>\n
- \nAvoid sudden discontinuation or rapid dose reduction with CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.\n<\/li>\n
- \nYou may take CREXONT with or without food; but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.\n<\/li>\n
- \nSwallow CREXONT whole. Do not chew, divide, or crush the capsules.\n<\/li>\n
- \nDo not take CREXONT with alcohol.\n<\/li>\n<\/ul>\n
Tell your healthcare provider if you:<\/b><\/p>\n
- \n
- \nHave any heart conditions, especially if you have had a heart attack or irregular heartbeats.\n<\/li>\n
- \nExperience hallucinations or abnormal thoughts and behaviors.\n<\/li>\n
- \nHave an inability to control urges to gamble, have increased sexual urges, or experience other intense urges.\n<\/li>\n
- \nHave thoughts of suicide or have attempted suicide.\n<\/li>\n
- \nHave abnormal involuntary movements that appear or get worse during treatment.\n<\/li>\n
- \nHave ever had a peptic ulcer or glaucoma.\n<\/li>\n
- \nBecome or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm.\n<\/li>\n
- \nAre breastfeeding during therapy.\n<\/li>\n
- \nHave side effects; your doctor can adjust your dose.\n<\/li>\n<\/ul>\n
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or <\/b>www.fda.gov\/medwatch<\/b><\/a>.<\/b><\/p>\n
\nPlease read the full Prescribing Information<\/a>. For more information talk to your healthcare provider.\n<\/p>\n
About Amneal
\n
<\/b>Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com<\/a> and follow us on LinkedIn<\/a>.\n<\/p>\nCautionary Statement on Forward-Looking Statements
\n
<\/b>Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management\u2019s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as \u201cplans,\u201d \u201cexpects,\u201d \u201cwill,\u201d \u201canticipates,\u201d \u201cestimates,\u201d and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company\u2019s filings with the Securities and Exchange Commission, including under Item 1A, \u201cRisk Factors\u201d in the Company\u2019s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.\n<\/p>\nReferences:<\/b><\/p>\n
\n(1)\u00a0Stocchi F et al. Parkinsonism Relat Disord. 2014;20(2):204-211.\n<\/p>\n
<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250403876544\/en\/<\/a><\/span><\/p>\n
Investor Contact
\n<\/b>
Anthony DiMeo
\n
VP, Investor Relations
\n
anthony.dimeo@amneal.com<\/a><\/p>\nMedia Contact
\n<\/b>
Randi Kahn
\n
SVP, Corporate Affairs, Syneos Health
\n
randi.kahn@syneoshealth.com<\/a><\/p>\nAmneal Medical Affairs
\n<\/b>
888-990-AMRX (2679)
\n
askamrx@amneal.com<\/a><\/p>\nKEYWORDS:<\/b> United States North America New Jersey<\/p>\n
INDUSTRY KEYWORDS:<\/b> Neurology Mental Health Health Pharmaceutical Health Insurance<\/p>\n
- More \u201cGood On\u201d time with less frequent dosing:<\/b> A head-to-head clinical trial showed CREXONT provides more \u201cGood On\u201d time per day, and 1.55 more hours of \u201cGood On\u201d time per dose (where symptoms are well-controlled without troublesome involuntary movements) compared to IR CD\/LD. This represents a 70% increase in the amount of time each dose helps people feel in control of their PD symptoms.\n<\/li>\n
- Increases insurance coverage to over 50% of covered lives<\/i><\/li>\n
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