Amneal Pharmaceuticals’ extended-release capsule for Parkinson’s disease has been approved by the FDA following an initial rejection last year.
The treatment, which will be marketed as Crexont, is a new formulation of levodopa and carbidopa. It was rejected by the FDA in 2023 with a complete response letter, in which the agency said that safety was not adequately established for one of the drugs in the combo: carbidopa. At the time, Amneal said it would work with the agency to address any safety concerns.
The specialty drugmaker resubmitted its NDA for Crexont in February, including data from a healthy volunteer study which was conducted in the fourth quarter of last year.
This combination of drugs has been approved since 1975, but Amneal set out to create a treatment that could last longer and require fewer daily doses.
Amneal has been working on this approval for several years. It announced positive late-stage data in 2021, demonstrating superior time without dyskinesia — called “Good On” time — from baseline in hours per day at the end of the 13-week double-blinded treatment period. That was the primary endpoint of the trial, called RISE-PD.
Compared to an immediate-release formulation, Amneal said that its treatment demonstrated a statistically significant improvement of 0.5 hours of additional “Good On” time per day, with an average of three times a day dosing with Amneal’s drug compared to five times a day dosing with the immediate-release option. The most common adverse reactions were anxiety and nausea.
A post-hoc analysis of the primary endpoint also showed an additional 1.6 hours of “Good On” time per dose of Crexont, compared to an immediate-release combo.