FDA accepts NDA for extended-release carbidopa/levodopa Parkinson’s treatment

The FDA has accepted a new drug application from Amneal Pharmaceuticals Inc. for IPX203, an oral formulation of carbidopa/levodopa extended-release capsules for treatment of Parkinson’s disease, the company announced in a press release.

According to the release, the novel carbidopa/levodopa (CD/LD) formulation contains immediate-release granules and extended-release beads and is distinct from Rytary, Amneal’s extended-release CD/LD capsules that received FDA approval in 2015. The company submitted the IPX203 new drug application for review on Aug. 31.

“The FDA filing acceptance of IPX203 marks another important milestone for Amneal as we strive to improve the lives and care of people living with Parkinson’s disease,” Amneal Chief Commercial Officer Gustavo Pesquin said in the release. “We look forward to engaging in conversations with the FDA as we advance the application. We believe the data in our RISE-PD study supports the important benefit IPX203 can offer to this community by providing longer duration of symptom control with the benefit of fewer doses.”

The RISE-PD phase 3 clinical trial showed that IPX203 provided 1.55 more hours of “good on” time — time without dyskinesia — compared with immediate-release CD/LD, the release stated. The trial was conducted at 105 clinical sites in the U.S., Europe and the U.K. and included 506 patients with PD.

“Amneal aims to provide people living with Parkinson’s disease effective treatments that allow them to live their lives with less concern about their mobility and symptoms and more freedom to choose how to spend their time,” Pesquin said. “We are pleased that IPX203 has the potential to address this need by extending periods when symptoms are better controlled, with less frequent dosing.”