Amneal Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. 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 3 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 Officer. “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.”
Many people living with PD experience motor fluctuations as part of their symptoms. “On” time refers to periods when these symptoms are better controlled, and patients can move and function better. Extending “Good On” time and reducing “Off” time are often key goals for patients, caregivers and healthcare providers as this can provide more consistent symptom control throughout the day.
CD/LD has been the gold standard of treatment for PD since the 1970s, but additional options are needed that can help patients function more consistently with an increase in “Good On” time per dose. Based on data in the Amneal clinical trials, IPX203 can offer patients additional “Good On” time with reduced dose frequency compared to immediate-release CD/LD.
“We are very pleased to submit our NDA for IPX203,” said Chirag Patel, Co-Chief Executive Officer. “As leaders in the PD space, Amneal knows how important it is for patients to achieve more ‘Good On’ time and live each day the way they choose. We are confident IPX203 can help them accomplish that goal.”