Clinical TrialJun 5, 2026, 08:01 AM
Amneal's CREXONT Phase 4 Study Shows Significant Parkinson's Benefits
AI Summary
Amneal Pharmaceuticals announced positive interim results from its Phase 4 ELEVATE-PD study for CREXONT (carbidopa and levodopa) extended-release capsules. The study, involving 214 patients, demonstrated clinically meaningful benefits, including substantial increases in "Good On" time, reductions in "Off" time, and improved motor function, regardless of prior treatment. Patients switching from RYTARY® nearly doubled their continuous "Good On" intervals. The safety profile was consistent with prior therapy, and the company recently received an FDA labeling update for an additional administration option.
Key Highlights
- CREXONT increased daily "Good On" time by +3.33 hours for IR CD/LD switchers.
- Daily "Off" time reduced by –3.20 hours for IR CD/LD switchers.
- MDS-UPDRS Total Scores improved by –14.6 points for IR CD/LD switchers.
- Patients switching from RYTARY gained 3.03 hours of additional daily "Good On" time.
- Continuous "Good On" intervals nearly doubled for RYTARY switchers, increasing by 3.08 hours.
- Daily motor fluctuations reduced by 2.26 (42.80%) for RYTARY switchers.
- Most common adverse events were dizziness (8.2%), fall (6.9%), nausea (6.5%), dyskinesia (6.5%).
Price Impact
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