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Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease
Interim data show substantial improvements in “Good On” time compared to other oral CD/LD therapiesCREXONT delivered substantial “Off” time reductions,
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"Interim data show substantial improvements in “Good On” time compared to other oral CD/LD therapiesCREXONT delivered substantial “Off” time reductions, improved motor symptom control and provided a longer duration of benefit with each doseFindings highlight CREXONT as a key therapy in a category with limited innovationELEVATE-PD study is ongoing with longer-term data expected in 2026 BRIDGEWATER, N.J., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, presented at the Parkinson’s Study Group (PSG) Annual Meeting. 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.1 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 today.2-4* “These early results confirm what clinicians are already seeing every day—patients on CREXONT feel better, stay ‘On’ longer, and experience more predictable control of their symptoms,” said Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, FL. “For Parkinson’s patients and the clinicians who care for them, this represents a real-world step forward in how we can manage the disease day-to-day.” “The ELEVATE-PD study interim results showcase CREXONT’s differentiated clinical performance and substantial real-world benefit,” said Dr. Avinash Desai, Senior Vice President and Chief Scientific Officer, Specialty, at Amneal Pharmaceuticals. “These interim results reinforce what patients and providers are already experiencing: CREXONT is measurably improving daily function and elevating care for people living with Parkinson’s. In a field with limited i...