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Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease
- IPX203 could offer people living with Parkinson’s disease a longer duration of symptom control with less frequent dosing compared to IR CD/LD treatment -
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\n- IPX203 could offer people living with Parkinson’s disease a longer duration of symptom control with less frequent dosing compared to IR CD/LD treatment\n\n- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 30, 2023.\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced 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.\n\n“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,” said Gustavo Pesquin, Chief Commercial Officer, Amneal Specialty. “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.”\n\nCD/LD has been the leading treatment for PD since the 1970s. Data from the pivotal 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.\n\n“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,” said Pesquin. “We are pleased that IPX203 has the potential to address this need by extending periods when symptoms are better controlled, with less frequent dosing.”\n\nThe FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 30, 2023 to complete its evaluation of the NDA.\n\nAbout the RISE-PD Trial\n\nThe multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX203 CD/LD extended-release capsules compared with immediate-release CD/LD in the treatment of people living with PD who have motor fluctuations.\n\nThe trial consisted of a 3-week, open-label immediate-release CD/LD dose adjustment period and a...