Crexont Extended-Release Capsules Approved for Parkinson Disease

The FDA has approved Crexont (carbidopa and levodopa; Amneal Pharmaceuticals, Bridgewater, NJ) extended-release capsules for the treatment of Parkinson disease (PD). Crexont combines immediate-release granules and extended-release pellets as a novel, oral formulation of carbidopa/levodopa, providing longer “Good On” time and reducing the frequency of doses compared with other immediate-release carbidopa/levodopa treatments.

The approval is based on results of the phase 3 RISE-PD clinical trial (NCT03670953) in which 506 participants were randomly assigned to receive either Crexont (n=256) or immediate-release carbidopa/levodopa (n=250). The primary endpoint, which was statistically significant improvement in “Good On” time for Crexont vs immediate-release carbidopa/levodopa, was met (least squares mean, 0.53 hours; 95% CI, .09 to .97; P=.02).

“Good On” time was calculated based on data obtained from participant diaries by adding the number of half-hour intervals in which either an “On” with no dykinesia or “On” with nontroublesome dykinesia was checked.

• Crexont was dosed a mean 3 times per day compared with 5 times per day for immediate-release carbidopa/levodopa.
• People treated with Crexont demonstrated an increase in “Good On” time by 1.55 hours compared with immediate-release carbidopa/levodopa (95% CI, 1.37 to 1.73; P<.001).
• The safety profile for Crexont was shown to be consistent with existing immediate-release carbidopa/levodopa therapies with the most common adverse events (AEs) being nausea and anxiety.

"The treatment goals for people living with Parkinson’s disease include achieving a more robust duration of benefit per dose of LD, reducing ‘Off’ time, and simplifying dosing regimens,” said Robert A. Hauser, MD, Professor of Neurology at the University of South Florida and Director of the Parkinson’s Disease and Movement Disorders Center. “CREXONT’s longer ‘Good On’ time per day and per dose represents a substantial advancement in managing motor symptoms and maintaining more consistent therapeutic effects, which is very encouraging for both patients and the Parkinson’s community.”

According to a statement from Amneal Pharmaceuticals, the company plans to make Crexont available by September 2024.