Amneal's CREXONT Shows Sleep Quality Improvement In Patients With Parkinson's Disease

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(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX), Monday announced data from a new analysis of the pivotal RISE-PD Phase 3 study, evaluating the efficacy and safety of CREXONT compared with IR CD/LD in the treatment of patients with Parkinson's disease or PD.

The analysis showed that patients on CREXONT experienced statistically significant improvements in sleep quality, which were measured using Parkinson's Disease Sleep Scale-2 or PDSS-2, showing a mean difference of -2.35 (p<0.0001) in total scores.

Additionally, the participants experienced statistically significant improvements across all PDSS-2 subdomains, including reduced disturbed sleep, improved nighttime motor symptoms, and PD symptoms at night.

Moreover, a separate study analysis revealed that there was a significant increase in the number of patients who reported waking up in an "On" state and patients who never recorded being in an "Off" state upon awakening.

The full findings of both analysis will be presented at the American Academy of Neurology 2025 Annual Meeting on April 9 at 8 a.m. PST.

The biopharmaceutical company has commenced a Phase 4 clinical trial, ELEVATE-PD, to evaluate the real-world efficacy and safety of CREXONT in patients with PD.

In the pre-market hours, Amneal's stock is trading at $7.15, down 3.12 percent on the Nasdaq.