Amneal Pharmaceuticals Inc. (NASDAQ: AMRX) announced interim results from its Phase 4 ELEVATE-PD study showing clinical benefits for patients with Parkinson's disease who switched to CREXONT, the company's extended-release carbidopa and levodopa capsules.

The study evaluated 214 patients after six weeks of treatment. Patients who switched from immediate-release carbidopa/levodopa gained 3.33 hours of daily "Good On" time, while those switching from RYTARY gained 3.03 hours. "Good On" time refers to periods when patients experience effective symptom control.

Patients switching from RYTARY showed additional improvements, with the duration of continuous "Good On" intervals nearly doubling from 3.19 hours at baseline to 6.27 hours at week six. Daily motor fluctuations decreased by 42.80% in this group.

The study also showed reductions in "Off" time across all patient groups, with decreases ranging from 2.4 to 3.20 hours daily. Motor function scores improved by 9.9 to 14.6 points on the MDS-UPDRS scale.

Common adverse events included dizziness (8.2%), falls (6.9%), nausea (6.5%), and dyskinesia (6.5%). The company stated these were generally mild to moderate and consistent with prior therapy.

CREXONT uses a mucoadhesive polymer technology designed to optimize levodopa delivery. The drug received FDA approval with updated labeling in May 2026 allowing patients to open capsules and sprinkle contents on applesauce for those with swallowing difficulties.

The ELEVATE-PD study enrolled 232 participants and continues with a 12-month follow-up period. Amneal plans to present longer-term outcomes throughout 2026.