Amneal Announces Positive Topline Results from Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations
(January 4, 2022) – Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced positive topline results from their pivotal Phase 3 RISE-PD clinical trial evaluating the novel formulation, IPX-203, in patients with Parkinson’s disease (PD) who have motor fluctuations. The trial demonstrated superior “Good On” time from baseline in hours per day at the end of the 13-week double-blind treatment period. Based on these results and other supportive data, Amneal plans to submit a New Drug Application (NDA) for IPX-203 with the U.S. Food and Drug Administration (FDA) in mid-2022. Click here to learn more about Amneal and IPX-203.