Amneal's Parkinson's Candidate Shows Efficacy In Pivotal Trial
- Amneal Pharmaceuticals Inc (NYSE: AMRX) announced topline data from the Phase 3 RISE-PD trial evaluating IPX-203 in patients with Parkinson's disease who have motor fluctuations.
- Amneal plans to submit a marketing application for IPX-203 with the FDA in mid-2022.
- The study demonstrated statistically significant improvement in efficacy for IPX-203 compared to immediate-release CD/LD, even when IPX-203 was dosed on average 3 times per day and immediate-release CD/LD was dosed on average 5 times per day.
- IPX-203 treatment resulted in 0.53 more hours of "Good On" time than immediate-release CD/LD when comparing change from baseline.
- The secondary endpoint for change from baseline in "Off" time showed IPX-203 resulted in significantly less "Off" time compared with immediate-release CD/LD (-0.48 hr).
- Analysis of the secondary endpoint for Patients' Global Impression of Change (PGI-C) scores showed 29.7% of patients treated with IPX-203 were "much improved" or "very much improved" compared with 18.8% of patients treated with immediate-release CD/LD.
- Eight subjects reported serious adverse events (SAEs) in the IPX-203 study arm and four (1.6%) subjects in the immediate-release CD/LD arm.
- Treatment-emergent adverse events were reported as (108 [42.2%] for IPX-203, 79 [31.6%] for immediate-release CD/LD).
- The most common AEs were nausea, dry mouth, urinary tract infection, and fall.
- Also See: Amneal Q2 Earnings Tops Estimates; Backs FY21 Guidance.
- Price Action: AMRX shares are up 11% at $6.16 during the premarket session on the last check Thursday.
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