Amneal Seeks FDA Approval For Its Parkinson's Candidate

Amneal Seeks FDA Approval For Its Parkinson's Candidate
  • Amneal Pharmaceuticals Inc AMRX submitted a marketing application to the FDA seeking approval for IPX203, an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for Parkinson's disease.
  • The submission is based on results from the pivotal Phase 3 RISE-PD clinical trial demonstrating more "Good On" time than immediate-release CD/LD.
  • Related Content: Amneal Pharma Posts Mixed Q2 Earnings, Cuts Profit Outlook For 2022.
  • IPX203 was dosed on average three times per day, and immediate-release CD/LD was dosed on average five times per day. The trial also showed that subjects on IPX203 demonstrated significantly less "Off" time compared with immediate-release CD/LD. 
  • A post-hoc analysis showed that IPX203 provided 1.55 more hours of "Good On" time per dose versus immediate-release CD/LD, representing a 70% per dose increase.
  • Price Action: AMRX shares are up 1.61% at $2.21 on the last check Thursday.

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