Amneal Launches CREXONT (Carbidopa and Levodopa) Extended-Release Capsules for Treatment of Parkinson's Disease

Business Wire 23-Sep-2024 8:00 AM

CREXONT now available in U.S. pharmacies nationwide

Comprehensive access and affordability services to be made available to Parkinson's patients and healthcare providers

Amneal to hold CREXONT launch symposium and scientific presentations at the International Congress of Parkinson's Disease and Movement Disorders on Sept. 27 – Oct. 1, 2024

Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company") today announced that it has launched CREXONT^® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson's disease. CREXONT^® is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release granules and extended-release pellets. CREXONT is now broadly available at U.S. pharmacies.

"We are pleased to launch CREXONT and make it broadly available to healthcare providers and patients. The product's innovative formulation provides a longer duration of "Good On" time with less frequent dosing compared to immediate release CD/LD. As a leader in the Parkinson's space, Amneal has a long history of working closely with movement disorder specialists and neurologists. We are excited to build on this foundation with the rollout of a comprehensive education program and extensive services to help healthcare providers and patients access this innovative therapy," said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty.

Information for Physicians and Patients:

• CREXONT is available only through prescription.
• Amneal sales representatives will begin scheduling appointments with healthcare providers on Sept. 23, 2024.
• Samples of CREXONT will be available to healthcare providers beginning on Sept. 23, 2024.
• Eligible commercially insured patients may qualify for a $25 copay on their prescriptions, applied automatically for most patients at the pharmacy through the CREXONT Savings Program.
• Eligible patients will be able to have their CREXONT prescriptions covered through the Amneal Patient Assistance Program.
• CoverMyMeds^® is a prior authorization (PA) solution that helps patients access CREXONT by streamlining the process for healthcare providers and pharmacists.
• Amneal understands the importance of access and affordability, particularly in the context of a new product launch. To support healthcare providers, the Company's Field Reimbursement Specialists will be available to advise on CREXONT beginning Sept. 23, 2024.

International Congress of Parkinson's Disease and Movement Disorders

Amneal will hold the following CREXONT events at this year's International Congress of Parkinson's Disease and Movement Disorders being held in Philadelphia, PA on Sept. 27 – Oct. 1, 2024:

• Dr. Robert Hauser, CREXONT principal investigator, will present a launch symposium introducing CREXONT on Friday, Sept. 27, 2024 at 1:30 pm ET entitled: Innovation in "On" time is here: introducing CREXONT^® (carbidopa and levodopa) extended-release capsules.
• An abstract will be presented highlighting motor states upon awakening with CREXONT (IPX203):Abstract Title: Impact of IPX203 on Parkinson's patients' motor states upon awakening: analysis of patient diary data Abstract Number: 688 Abstract Category: Parkinson's Disease: Clinical Trials Presentation Date and Time: Sunday, September 29, 1:00-3:00 pm EDT Poster Hall: Exhibit Hall A

For additional information about the International Congress of Parkinson's Disease and Movement Disorders, please click here.

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 Parkinson's Disease Parkinson's disease (PD) has become the fastest growing neurological disorder worldwide, with approximately 1 million people diagnosed in the U.S.^1,2 It is a progressive disorder of the central nervous system (CNS) that affects dopamine-producing neurons in the brain that affect movement. PD is characterized by slowness of movement, stiffness, resting tremor and impaired balance.³ While PD is not considered a fatal disease, it is associated with significant morbidity and disability.⁴ The average age at diagnosis for people with PD is 60; as people live longer, the number of people living with PD is predicted to grow significantly over the coming decades.^1,5

About Amneal Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics 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, with a pipeline focused on unmet needs. 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.

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. Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
2. Marras et al. NPJ Parkinson's Dis. 2018;4:21.
3. NINDS. Parkinson's disease: challenges, progress, and promise. Reviewed August 2019.
4. Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
5. John Hopkins Medicine. Young-Onset Parkinson's disease.

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