The RISE-PD Study of IPX-203: Alberto J. Espay, MD, MSc

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“As it happens with many of these trials, most of the patients who came on to this trial had a good 6 hours or so of baseline OFF time. What was interesting is the study was really positive in terms of both a demonstration of a good ON time compared to immediate-release carbidopa/levodopa as well as a corresponding reduction in the OFF time.”

In August, Amneal Pharmaceuticals announced positive topline results from its pivotal phase 3 clinical trial, RISE-PD (NCT03670953) that evaluated the company’s investigational formulation, IPX-203, in individuals with Parkinson disease (PD) who experience motor fluctuations.

The trial was conducted at 108 clinical sites in the US and Europe and randomized 506 patients with PD aged 40 years and older. Currently, a 9-month safety extension study is ongoing. RISE-PD met its primary end point, demonstrating more good ON time from baseline after the 13-week double-blind treatment period. Amneal also announced that based on the results and other supportive data it holds, it plans to submit a new drug application for IPX-203 with the FDA in mid-2022.

Alberto J. Espay, MD, MSc, professor of neurology, director, James J. and Joan A. Gardner Family Center, and research chair, Parkinson’s Disease and Movement Disorders, University of Cincinnati Health, offered an overview of the trial in a conversation with NeurologyLive. Espay, an investigator in the trial, shared his insight on the findings and IPX-203’s potential to offer benefit to patients.

REFERENCE
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. News release. Amneal Pharmaceuticals. August 25, 2021. Accessed October 12, 2021. https://www.businesswire.com/news/home/20210825005679/en/Amneal-Announces-Positive-Topline-Results-from-Pivotal-Phase-3-RISE-PD-Clinical-Trial-of-IPX-203-in-Patients-with-Parkinson%E2%80%99s-Disease-Who-Experience-Motor-Fluctuations