In the pivotal Phase III trial, Amneal’s investigational Parkinson’s drug, IPX-203, met its primary endpoint, demonstrating superior “Good On” time in patients with motor fluctuations.
Many patients with Parkinson’s disease struggle daily to effectively manage motor fluctuations, leading to quality-of-life challenges ranging from depression to difficult medication schedules. Yesterday, New Jersey-based Amneal Pharmaceuticals announced a potential therapeutic step forward in managing this debilitating symptom.
In Parkinson’s disease, the cells that produce dopamine, a neurotransmitter that sends signals between nerve cells in the brain, die off, leading to a condition called Dyskinesia. Patients experience involuntary and abnormal movements such as twitching, jerking, and writhing.
“Despite the introduction of several new medications for Parkinson’s disease in recent years, new treatment options are needed that provide longer-lasting duration of benefit with each dose and simplify medication regimens for patients affected by this devastating disease,” said Dr. Alberto Espay, professor of neurology at the University of Cincinnati and director of the James J. and Joan A. Gardner Family Center.
In its pivotal Phase III RISE-PD clinical trial, Amneal’s investigational Parkinson’s drug, IPX-203, met its primary endpoint, demonstrating superior “Good On” time in patients with motor fluctuations. When compared to immediate-release oral carbidopa/levodopa (CD/LD), the established standard treatment for motor fluctuation in Parkinson’s, extended-release IPX-203 capsules provided study participants with 0.53 more hours of “Good On” time, even when dosed an average of three times per day as opposed to five doses for the former.
IPX-203 also excelled in meeting its secondary endpoint, demonstrating significantly less “off-time”. Based on reporting, Patients’ Global Impression of Change (PGI-C) scores were “much improved” or “very much improved” for 29.7% of patients on treatment with the drug compared with 18.8% of patients receiving immediate-release CD/LD.
Negative reactions were minimal, with eight participants (3.1%) treated with IPX-203 reporting serious adverse events (AEs) compared with four subjects (1.6%) in the immediate-release CD/LD study arm. The most common treatment-emergent AEs were nausea, dry mouth, urinary tract infection and falls.
“The topline data from RISE-PD indicates that IPX-203 has the potential to offer patients superior ‘Good On’ time with reduced dosing frequency, compared to immediate-release CD/LD,” said Dr. Robert A. Hauser, professor of Neurology at the University of South Florida and director of the Parkinson’s Disease and Movement Disorders Center.
Amneal is a diversified pharmaceutical company whose specialty pharma R&D pipeline includes programs in central nervous system disorders, endocrinology and parasitic infections.
Based on the results of the RISE-PD trial, which was conducted with 506 randomized patients 40 years and older at 108 clinical sites across the United States and several European countries, Amneal plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in mid-2022.
“These positive data from the Phase 3 trial of IPX-203 represent a substantial step forward in strengthening Amneal’s Specialty Pharma portfolio, which is heavily focused on medicines for central nervous system disorders,” said Amneal co-Chief Executive Officers, Chirag and Chintu Patel. “We look forward to submitting an NDA with the FDA and potentially making this treatment available to the PD community.”
