FDA Approves Amneal’s CREXONT for Parkinson’s Treatment

The US Food and Drug Administration (FDA) has given its approval to Amneal Pharmaceuticals' latest development, the CREXONT extended-release capsules, designed for the treatment of Parkinson's disease (PD). This innovative oral formulation of carbidopa (CD) and levodopa (LD) aims to enhance the consistency of "good on" time for patients, which refers to periods without troublesome dyskinesia, or involuntary movements and muscle spasms.

In clinical evaluations, specifically the RISE-PD trial, CREXONT demonstrated a statistically significant improvement in the "good on" time for PD patients. Participants in the trial experienced an additional 0.5 hours per day of "good on" time compared to those taking the immediate-release form of CD/LD. This improvement was achieved with CREXONT's regimen of just three doses daily, as opposed to the five doses required with the immediate-release version. Furthermore, a post-hoc analysis indicated that each dose of CREXONT provided an additional 1.6 hours of "good on" time.

CREXONT's formulation includes both immediate-release granules and extended-release pellets, ensuring rapid onset of action combined with sustained efficacy. The safety profile of CREXONT aligns with that of the immediate-release CD/LD, with the most frequently reported side effects being nausea and anxiety.

Amneal Pharmaceuticals plans to launch CREXONT capsules in the US market by September 2024, providing a new therapeutic option for managing Parkinson's disease. The newly approved formulation and its dosage strengths differ from those of RYTARY, another extended-release carbidopa and levodopa capsule previously approved by the FDA.

Chirag and Chintu Patel, co-CEOs of Amneal, emphasized the significance of this approval, stating, "The approval of CREXONT marks a pivotal moment in the treatment paradigm for Parkinson's disease. The burden of this incurable neurodegenerative condition increases over time, and some patients on immediate-release CD/LD can require up to ten doses daily, still facing motor fluctuations." They highlighted that CREXONT’s innovative formulation offers a longer duration of "good on" time with less frequent dosing compared to immediate-release CD/LD, expressing excitement about introducing this valuable treatment to Parkinson's patients in the US and internationally in the near future.