Business
Amneal to Present Results From the Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 at the 2022 American Academy of Neurology Annual Meeting
- First presentation at a medical meeting of topline results and post hoc analysis - Positive topline results were previously announced in August 2021
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\n- First presentation at a medical meeting of topline results and post hoc analysis \n\n- Positive topline results were previously announced in August 2021\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that results from the pivotal Phase 3 RISE-PD clinical trial evaluating the novel investigational extended-release CD/LD formulation, IPX-203, in Parkinson’s disease patients with motor fluctuations, will be presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, WA.\n\nThe data are being presented for the first time at AAN and are consistent with the positive topline results announced last year. Amneal plans to submit a New Drug Application for IPX-203 in the second quarter of 2022. Amneal’s abstracts at AAN will include:\n\nA Phase 3 Trial of IPX-203 vs. Immediate Release CD/LD in Parkinson’s Disease Patients with Motor Fluctuations (RISE-PD); Hauser, R. et al.\n\nSession S16: Movement Disorders: PD Biomarkers and Clinical Trials; Monday, April 4; 5:18 PM PT\n\n\nLead investigator Robert A. Hauser, M.D., will present the topline results of the Phase 3 RISE-PD clinical trial as part of a scientific platform session at the AAN Annual Meeting in Seattle, WA.\n\n\nIn the trial, IPX-203 showed statistically significant improvement in “Good On” time compared to immediate release CD/LD, when dosed on average three times a day compared to five times a day for immediate release CD/LD.\n\n\nDuration of Benefit Per Dose: Post Hoc Analysis of “Good On” Time Per Dose for IPX-203 vs. Immediate Release CD/LD in the RISE-PD Phase 3 Trial; Hauser, R. et al.\n\nSession P10: Movement Disorders: Trials 2; Tuesday, April 5; 8:00 – 9:00 AM PT\n\n\nPost hoc analysis of Least Squares Mean difference at end of study (week 20) showed that IPX-203 provided 1.55 more hours of “Good On” time per dose versus immediate release CD/LD, representing a 70% increase.\n\n\n“The findings from a post hoc analysis of the RISE-PD trial indicated that IPX-203 may offer patients more ‘Good On’ time per dose, compared to immediate-release CD/LD. Increasing the amount of ‘Good On’ time, if confirmed, can reduce disruptions caused by troublesome dyskinesia and provide more consistent symptom control throughout the day,” said Robert A. Hauser, M.D., Professor of Neurology at the U...