On Aug. 7, 2024, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had approved CREXONT ^® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). CREXONT is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets. Amneal expects to make CREXONT available to patients in the U.S. in September 2024.

Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily “Good On” time, defined as “On” time without troublesome dyskinesia, as the disease progresses. There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One new patient is diagnosed with Parkinson’s disease every six minutes. In the treatment of PD, there is a need for improved oral CD/LD formulations that achieve more “Good On” time with fewer daily doses.

CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER 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.