Amneal submits new drug application for extended-release Parkinson’s treatment
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Amneal Pharmaceuticals Inc. announced it has submitted a new drug application to the FDA for IPX203, an oral formulation of carbidopa/levodopa extended-release capsules for the treatment of Parkinson’s disease.
According to a company release, the NDA submission is based on results from the phase 3 RISE-PD clinical trial, which demonstrated more “good on” time compared with immediate-release carbidopa/levodopa (CD/LD), even when IPX203 was administered on average three times per day and immediate-release CD/LD was administered an average of five times per day.
Results from the trial also showed that participants given IPX203 had significantly less “off” time compared with immediate-release CD/LD. According to a post-hoc analysis at week 20 of the study, IPX203 provided 1.55 more hours of “good on” time per dose compared with immediate-release CD/LD, representing a 70% per dose increase, the company stated.
“We are committed to furthering the advancement of treatments that can provide longer-lasting duration of benefit with every dose and simplify medication regimens,” Chintu Patel, co-CEO of Amneal, said in the release. “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.”
Although CD/LD has been the gold standard of treatment for PD since the 1970s, additional options are needed to help patients achieve an increase in “good on” time per dose, the company stated in the release. Based on trial data, IPX203 can offer this benefit with reduced dose frequency compared with immediate-release CD/LD.
“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,” Chirag Patel, co-CEO of Amneal, said in the release. “We are confident IPX203 can help them accomplish that goal.”