Amneal Receives FDA Approval for Parkinson’s Treatment

Amneal Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its CREXONT extended-release capsules for Parkinson’s disease (PD) treatment. The oral carbidopa (CD)/levodopa (LD) formulation that makes up CREXONT aims to provide patients with a more consistent “good on” time, which relates to a period of time a patient is free of dyskinesia (involuntary movements and muscle spasms).

So far, CREXONT has successfully demonstrated that it can provide a significant improvement in “good on” time for patients. For example, a post-hoc analysis found that 1.6 hours of extra “good on” time can be secured per dose of CREXONT. The most common adverse reactions when receiving the treatment are nausea and anxiety.

“The approval of CREXONT is a seminal moment in the treatment paradigm for PD. The burden of this incurable neurodegenerative disease increases with time. Some PD patients on IR CD/LD [the mainstays of previous treatments] take up to 10 daily doses and still experience motor fluctuations,” said Chirag and Chintu Patel, Co-CEOs at Amneal. “CREXONT’s innovative formulation provides a longer duration of “good on” time with less frequent dosing compared to IR CD/LD. Amneal is so excited to introduce this meaningful new treatment for Parkinson’s patients in the US and soon internationally.”

The capsules are expected to be available to US patients in September 2024.