BRIDGEWATER, N.J., June 5, 2026
Amneal Pharmaceuticals announced positive interim results from the ongoing Phase 4 ELEVATE-PD study, demonstrating meaningful clinical benefits for patients with Parkinson’s disease who switched to CREXONT® (carbidopa and levodopa) extended-release capsules. The findings, presented at the Advanced Therapeutics in Movement & Related Disorders (ATRMD) 2026 Congress, included data from the full study population of 214 patients evaluated after six weeks of treatment. The results showed substantial increases in daily “Good On” time, significant reductions in “Off” time, and clinically meaningful improvements in motor function regardless of prior treatment regimen, further supporting CREXONT’s role as a differentiated therapy for Parkinson’s disease management.
Significant Improvements Across Prior Treatment Groups
The interim analysis demonstrated consistent benefits among patients switching to CREXONT from immediate-release carbidopa/levodopa, immediate-release carbidopa/levodopa combined with COMT inhibitors, and RYTARY® extended-release capsules. Patients experienced increases in daily “Good On” time ranging from 3.03 to 3.33 hours while reducing daily “Off” time by as much as 3.20 hours. In addition, improvements in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) scores reflected meaningful gains in overall motor symptom control. According to investigators, the reproducibility of these outcomes across different treatment groups highlights CREXONT’s ability to provide more predictable symptom management in routine clinical practice.
Notable Benefits Observed in Patients Switching from RYTARY
Among patients transitioning from RYTARY, CREXONT demonstrated particularly strong improvements in continuous symptom control. The average duration of uninterrupted “Good On” intervals nearly doubled, increasing from 3.19 hours at baseline to 6.27 hours after six weeks of treatment. Additionally, the average number of daily motor fluctuations decreased by more than 42%, indicating a substantial reduction in symptom variability throughout the day. These findings suggest that patients switching from other extended-release levodopa formulations may achieve longer periods of stable symptom control and improved daily functioning with CREXONT therapy.
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Building Long-Term Evidence in Parkinson’s Disease
CREXONT is Amneal’s next-generation extended-release carbidopa/levodopa formulation utilizing proprietary mucoadhesive polymer technology designed to optimize levodopa absorption and sustain therapeutic drug levels. The therapy recently received an FDA-approved labeling update allowing patients who have difficulty swallowing capsules to sprinkle the contents onto applesauce for administration. With enrollment in the ELEVATE-PD study now complete and participants continuing through a 12-month follow-up period, Amneal plans to present additional long-term efficacy, safety, and patient-reported outcomes throughout 2026. The growing body of evidence is expected to further define CREXONT’s impact on motor symptom control, functional independence, and quality of life for individuals living with Parkinson’s disease.
Source: Amneal Pharmaceuticals, press release
