FDA approves Crexont extended-release capsules for Parkinson’s disease
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Key takeaways:
- Crexont was associated with about a half an hour more of “good on” time per day compared with immediate release formulations.
- The drug’s commercial launch in the United States is expected in September.
The FDA has approved Crexont extended-release capsules for the treatment of Parkinson’s disease, according to the manufacturer.
Amneal Pharmaceuticals Inc. said in a press release that Crexont — formerly known as IPX203 — is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release pellets.
Crexont was examined in the RISE-PD study, a 20-week, randomized, double-blind, active-controlled, phase 3 clinical trial held at 105 academic and clinical centers throughout the United States and Europe.
Results showed that Crexont offered about 30 more minutes of “good on” time per day compared with IR CD/LD. A post-hoc analysis of efficacy on a per dose basis found that treatment with Crexont led to 1.6 more hours of “good on” time per dose, compared with IR CD/LD.
Additionally, Crexont’s safety profile was consistent with IR CD/LD, according to the release.
Amneal submitted an initial new drug application to the FDA in 2022 for the investigative therapeutic, which was accepted in November of that year.
However, in July 2023, the FDA declined to approve Amneal’s proposed formulation based on a lack of evidence to support the safety of its proportion of carbidopa.
The commercial release of Crexont in the United States is expected in September, Amneal said in the release.
“The approval of Crexont is a seminal moment in the treatment paradigm for Parkinson’s disease, as the burden of this incurable neurodegenerative disease increases with time,” Amneal co-CEOs Chirag and Chintu Patel said in the release. “Some patients on IR CD/LD take up to 10 daily doses and still experience motor fluctuations. We are committed to continuing to advance Parkinson’s research and development as a leader in the space.”