IPX203 is a new oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules that comprises extended-release (ER) coated beads and immediate-release (IR) granules.
The company’s NDA submission is based on the data obtained from the pivotal Phase III RISE-PD clinical trial, which was conducted at 105 clinical locations in the US and European countries, including Spain, Czechia, Poland, the UK, France, Italy, and Germany.
The double-blind, multicentre, parallel-group, double-dummy, randomised, active-controlled RISE-PD clinical trial has assessed the IPX203 CD/LD extended-release capsules’ safety and efficacy compared with immediate-release CD/LD to treat PD patients with motor fluctuations.
The study showed more “Good On” time even when IPX203 was given on average three times a day, as against immediate-release CD/LD given on average five times a day.
“Good On” time is referred as the sum of “On” time with non-troublesome dyskinesia and without dyskinesia.
The findings demonstrated that the participants who received IPX203 had significantly less “off” time compared with immediate-release CD/LD.
Amneal Pharmaceuticals co-chief executive officer Chintu Patel said: “We are committed to furthering the advancement of treatments that can provide longer-lasting duration of benefit with every dose and simplify medication regimens.
“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.”