Amneal Announces Expanded Coverage for CREXONT® (Carbidopa and Levodopa) to Enhance Access for Parkinson’s Disease Patients in the U.S.

• CREXONT added to 3 large national formularies: Veterans Administration, UnitedHealthcare and CVS Health
• Increases insurance coverage to over 50% of covered lives
• CREXONT was approved by the U.S. FDA to treat Parkinson’s disease in 2024

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that three large insurance coverage accounts, the Veterans Administration (VA), UnitedHealthcare and CVS Health, have added CREXONT^® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s 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.

This expanded coverage increases CREXONT’s 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—achieved nine months ahead of schedule—a testament to Amneal’s 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 “preferred” product to its national formulary on July 1, 2025.

“We are extremely proud to announce the addition of CREXONT on three major insurance platforms,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty at Amneal Pharmaceuticals. “Achieving 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.”

CREXONT’s therapeutic benefits include:

• Novel formulation designed to provide long lasting efficacy: 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 “Off” time. About half of patients taking a PD medication may experience “Off” episodes – time where their motor symptoms return or are not well-controlled – within 2 to 3 years of treatment initiation.¹
• More “Good On” time with less frequent dosing: A head-to-head clinical trial showed CREXONT provides more “Good On” time per day, and 1.55 more hours of “Good On” 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.
• Safety profile consistent with IR CD/LD: The most common adverse reactions with CREXONT (incidence ≥3% and greater than IR CD/LD) are nausea and anxiety. See Important Safety Information below.

To 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/ or call 1-877-764-9021 Monday-Friday 8:00AM-5:00PM CST for live support.

About CREXONT^®
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^® (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015. Learn more about CREXONT at crexont.com.

INDICATION
CREXONT (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.

IMPORTANT SAFETY INFORMATION

• Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.
• Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.
• CREXONT 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.
• The most common side effects that may occur with CREXONT are nausea and anxiety.
• Avoid 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.
• You 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.
• Swallow CREXONT whole. Do not chew, divide, or crush the capsules.
• Do not take CREXONT with alcohol.

Tell your healthcare provider if you:

• Have any heart conditions, especially if you have had a heart attack or irregular heartbeats.
• Experience hallucinations or abnormal thoughts and behaviors.
• Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges.
• Have thoughts of suicide or have attempted suicide.
• Have abnormal involuntary movements that appear or get worse during treatment.
• Have ever had a peptic ulcer or glaucoma.
• Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm.
• Are breastfeeding during therapy.
• Have side effects; your doctor can adjust your dose.

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 www.fda.gov/medwatch.

Please read the full Prescribing Information. For more information talk to your healthcare provider.

About Amneal
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 and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements
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’s 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 “plans,” “expects,” “will,” “anticipates,” “estimates,” 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’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s 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.

References:

(1) Stocchi F et al. Parkinsonism Relat Disord. 2014;20(2):204-211.

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Source: Amneal Pharmaceuticals, Inc.