Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease (PD). IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules.
CD/LD has been the leading treatment for PD since the 1970s. Data from the Phase 3 RISE-PD clinical trial found that IPX203’s extended-release formulation offers significantly more “Good On” time, as well as significantly less “Off” time, compared to immediate-release CD/LD, even when dosed less frequently.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 30, 2023 to complete its evaluation of the NDA.