Amneal's CREXONT Shows Sleep Benefits for Parkinson's Patients in Phase 3 Study

Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, today announced a new analysis of the pivotal RISE-PD Phase 3 study showed that patients who successfully converted to CREXONT from immediate release (IR) carbidopa/levodopa (CD/LD) experienced statistically significant improvements in sleep quality. These improvements were measured by their Parkinson's Disease Sleep Scale-2 (PDSS-2) total scores, showing a mean difference of -2.35 (p<0.0001).

CREXONT, which is indicated for the treatment of Parkinson's disease (PD), is a novel formulation of CD/LD that combines both IR granules and extended-release pellets. This innovative design allows for rapid onset, while leveraging a sustained-release polymer for slow LD release, potentially enabling longer LD absorption in the gut.

The new analysis showed that patients on CREXONT, compared to IR CD/LD, also experienced statistically significant improvements across all PDSS-2 subdomains, including reduced disturbed sleep (-1.07, p<0.0001), improved nighttime motor symptoms (‑0.62, p<0.0059) and PD symptoms at night (-0.65, p<0.0017). Full results will be presented at the American Academy of Neurology (AAN) 2025 Annual Meeting on April 9 at 8 a.m. PST.