BRIDGEWATER, N.J.– Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced positive topline results from the pivotal Phase 3 RISE-PD clinical trial that evaluated the novel formulation, IPX-203, in patients with Parkinson’s disease (PD) who have motor fluctuations. The trial met its primary endpoint, demonstrating superior “Good On” time from baseline in hours per day at the end of the 13-week double-blind treatment period with IPX-203 CD/LD extended-release capsules compared with immediate-release CD/LD. Based on these topline results plus 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.
Phase 3 topline results showed the study was successful in demonstrating 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 (p=0.0194), when comparing change from baseline (Week 7) in both study arms.
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, p=0.0252). In addition, 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 (p=0.0015). IPX-203 change from baseline scores for Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III or sum of MDS-UPDRS Part II and III were similar to those of immediate-release CD/LD.
A post-hoc analysis of Least Squares Mean difference at Week 20 (EOS/ET) showed IPX-203 increased “Good On” time by 1.55 hours per dose compared with immediate-release CD/LD (p<0.0001).
