FDA Approves Amneal's Novel Parkinson's Treatment Crexont
Amneal Pharmaceuticals Secures Approval for Extended-Release Carbidopa and Levodopa Formulation
BRIDGEWATER, N.J. --(BUSINESS WIRE)-- Amneal Pharmaceuticals Inc. (NYSE: AMRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Crexont® (carbidopa and levodopa extended-release capsules) for the treatment of Parkinson's disease. Crexont is a novel oral formulation designed to provide extended, controlled delivery of carbidopa and levodopa, offering potential benefits for patients with Parkinson's disease.
About Crexont
Crexont is an extended-release formulation of carbidopa and levodopa, two medications commonly used to treat Parkinson's disease. Carbidopa helps to reduce the side effects of levodopa, such as nausea and vomiting, while levodopa improves motor function in patients with Parkinson's disease.
Approval Based on Phase 3 Trial Results
The FDA's approval of Crexont is based on the results of a Phase 3 clinical trial, known as the RISE-PD trial. In the study, Crexont significantly improved "Good On-time" in patients with Parkinson's disease, meaning that patients spent more time in a stable, "on" state, with improved motor function and reduced "off" time.
Expanding Treatment Options for Parkinson's Patients
"We are very pleased to receive FDA approval for Crexont, which represents a significant milestone for Amneal and for patients with Parkinson's disease," said Robert Stewart, Chairman and CEO of Amneal. "Crexont is a valuable addition to our portfolio of Parkinson's treatments and offers patients a unique option for managing their symptoms."
Crexont is expected to be available in the United States in the first quarter of 2023.
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