Amneal files for FDA approval of Parkinson's candidate

Shares of US drugmaker Amneal Pharmaceuticals (NYSE: AMRX) closed down 7.7% at $2.17 yesterday, after it announced submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD).

The submission is based on results from the pivotal Phase III RISE-PD clinical trial demonstrating more “Good On” time compared to immediate-release CD/LD, even when IPX203 was dosed on average three times per day and immediate-release CD/LD was dosed on average five times per day. The trial also showed that subjects on IPX203 demonstrated significantly less “Off” time compared with immediate-release CD/LD. A post-hoc analysis of the Least Squares Mean difference at end of study (week 20) showed that IPX203 provided 1.55 more hours of “Good On” time per dose versus immediate-release CD/LD, representing a 70% per dose increase.

“We are committed to furthering the advancement of treatments that can provide longer-lasting duration of benefit with every dose and simplify medication regimens,” said Chintu Patel, co-chief executive, adding: “The RISE-PD data indicate IPX203 can offer patients a new and important treatment option that will enable them to have more “Good On” time during the day, which we believe would be a significant new benefit for Parkinson’s patients. We are working with the FDA to bring this treatment to market.”