Amneal's Combination Drug Shows Improved Sleep Quality In Parkinson's Disease Patients

Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) revealed a new analysis of the pivotal RISE-PD Phase 3 study on Monday.

The data showed that patients who converted to Crexont from immediate release (IR) carbidopa/levodopa (CD/LD) experienced improved 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).

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Crexont, indicated for Parkinson’s disease (PD), is a novel CD/LD formulation that combines 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).

A separate analysis of Hauser diary entries, a commonly used PD symptom tracking tool, from patients who completed the RISE-PD study will also be presented at AAN.

Treatment with CREXONT compared to IR CD/LD significantly increased the number of patients who reported waking up in an “On” state and patients who never recorded being in an “Off” state upon awakening.

Furthermore, the percentage of patients who never recorded “On” upon awakening decreased with Crexont vs. IR CD/LD.

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

Price Action: AMRX stock is down 2.85% at $7.17 at the last check Monday.

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