Amneal Launches CREXONT® Extended-Release for Parkinson’s Disease

Amneal Pharmaceuticals, Inc. has announced the launch of CREXONT®, a new extended-release capsule formulation of carbidopa and levodopa, designed for the treatment of Parkinson’s disease. This product, which combines immediate-release granules with extended-release pellets, is now available in pharmacies across the United States.

“Launching CREXONT marks a significant milestone for Amneal and will greatly benefit healthcare providers and patients. This innovative formulation extends the duration of 'Good On' time and requires less frequent dosing compared to immediate-release carbidopa/levodopa," stated Joe Renda, Amneal's Senior Vice President and Chief Commercial Officer of Specialty. He added that the company is also rolling out a comprehensive education program and various services to enhance access to CREXONT for both providers and patients.

For healthcare professionals and patients, CREXONT is available only by prescription. Starting September 23, 2024, Amneal sales representatives will be reaching out to healthcare providers to schedule appointments, and samples of CREXONT will also be made available to them. Commercially insured patients may benefit from the CREXONT Savings Program, which offers a $25 copay on prescriptions. Additionally, patients might have their prescriptions covered through the Amneal Patient Assistance Program.

To facilitate patient access, Amneal will employ CoverMyMeds®, a prior authorization solution streamlining the process for healthcare providers and pharmacists. To support healthcare providers with this new product, Amneal's Field Reimbursement Specialists will be available from September 23, 2024.

Amneal will also be present at the International Congress of Parkinson’s Disease and Movement Disorders in Philadelphia from September 27 to October 1, 2024. Dr. Robert Hauser, the principal investigator for CREXONT, will introduce the product at a symposium on September 27. Additionally, an abstract focusing on the impact of CREXONT on patients' motor states upon awakening will be presented on September 29.

CREXONT provides a combination of immediate-release granules and extended-release pellets, differing in formulation and dosage from RYTARY® extended-release capsules, which were approved by the FDA in 2015. It is designed to treat Parkinson’s disease and symptoms resulting from brain infection or inflammation, as well as similar symptoms caused by carbon monoxide or manganese poisoning.

Regarding safety, patients should avoid taking CREXONT with nonselective monoamine oxidase (MAO) inhibitors or other carbidopa-levodopa preparations without consulting their healthcare provider. Common side effects include nausea and anxiety, and patients are advised to avoid sudden discontinuation or rapid dose reduction without medical supervision. The medication should be swallowed whole and not taken with alcohol.

Patients are also advised to inform their healthcare provider of any heart conditions, hallucinations, abnormal thoughts, uncontrollable urges, suicidal thoughts, involuntary movements, history of peptic ulcers or glaucoma, pregnancy intentions, or if they are breastfeeding.

Parkinson’s disease is a progressive central nervous system disorder affecting dopamine-producing neurons, leading to symptoms such as slowness of movement, stiffness, tremors, and impaired balance. Although not fatal, Parkinson’s disease significantly affects morbidity and disability, with around one million people diagnosed in the U.S. alone.

Amneal Pharmaceuticals, headquartered in Bridgewater, New Jersey, is a global company specializing in the development, manufacturing, and distribution of over 280 generic and specialty pharmaceuticals primarily in the United States. The company is expanding its generics segment across various complex product categories and therapeutic areas, including injectables and biosimilars. Amneal’s specialty segment focuses on branded pharmaceuticals for central nervous system and endocrine disorders, with a pipeline aimed at addressing unmet medical needs. Through its AvKARE segment, the company also distributes pharmaceuticals and other products to the U.S. federal government and retail markets.