Amneal Pharmaceuticals 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.
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.