On Dec. 5, 2025, Amneal Pharmaceuticals announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study.

The first 55 patients evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to CREXONT^® (carbidopa and levodopa) extended-release capsules, including significant increases in daily “Good On” time, reductions in “Off” time, improved motor symptom control, and consistent gains in “Good On” time per dose—regardless of whether patients switched from immediate-release carbidopa/levodopa (IR CD/LD), IR CD/LD with a COMT inhibitor, or RYTARY^® (carbidopa and levodopa) extended-release capsules.

CREXONT is Amneal’s next-generation extended-release CD/LD formulation that uses a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption, providing the longest-lasting levodopa plasma levels of any oral CD/LD therapy available to today.

In the study, treatment-emergent adverse events (TEAEs) were generally mild to moderate and consistent with prior therapy. CREXONT should not be taken with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors. CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. The most common (≥3%) were nausea (5.5%), falls (3.6%), dizziness (3.6%), and urinary tract infection (3.6%).

Amneal will present longer-term outcomes and patient-reported results in 2026 as part of the ongoing, rolling ELEVATE-PD program, further strengthening the evidence for CREXONT’s impact on motor symptom control and functional independence.