FDA Approves Amneal's Fast-Acting, Extended-Release Parkinson's Duo

16 August 2024
The FDA approved a new formulation of the well-known Parkinson’s disease treatment, carbidopa and levodopa, which promises faster action and prolonged effectiveness. This updated medication, named Crexont and developed by Amneal, consists of immediate-release (IR) granules of carbidopa and levodopa for a quick onset of relief, coupled with extended-release (ER) pellets of levodopa for sustained efficacy.

The combination of carbidopa and levodopa (CD/LD) has been a cornerstone in Parkinson’s disease treatment since it was first approved as Sinemet back in 1975. Since then, various pharmaceutical companies have developed and received FDA approval for different formulations of this combination. Among these, Amneal’s own extended-release version, Rytary, received approval in 2015.

The latest approval for Crexont is grounded in data from the Phase III RISE-PD trial. This study compared the dual IR/ER formulation of Amneal’s product to an IR version of CD/LD. Results showed that Crexont provided a significant improvement, offering an additional 0.5 hours of “Good On” time per day. “Good On” time is defined as periods when Parkinson’s symptoms are minimal and there is no troublesome dyskinesia. Notably, Crexont achieved this with an average dosing schedule of three times daily, compared to the five times daily required for the IR formulation.

Safety data from the trial indicated that Crexont has a safety profile comparable to the IR version of CD/LD. The most frequently reported adverse reactions were mild, including nausea and anxiety.

Dr. Robert Hauser, director of the Parkinson's Disease and Movement Disorders Center, commented on the importance of Crexont's increased “Good On” time per day and per dose, highlighting it as a significant advancement in the management of motor symptoms and the maintenance of consistent therapeutic effects.

Amneal is planning to commercially launch Crexont in September, with plans for international distribution to follow shortly thereafter.

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