Amneal Phase 4 CREXONT Data Show Up to 3.33-Hour 'Good On' Gain
AMRX•Amneal's Phase 4 ELEVATE-PD interim results in 214 Parkinson's patients showed CREXONT extended-release capsules boosted daily 'Good On' time by 3.03–3.33 hours and cut 'Off' time by up to 3.20 hours across prior regimens. RYTARY-switch patients nearly doubled continuous 'Good On' intervals to 6.27 hours and cut motor fluctuations 42.8%.
1. ELEVATE-PD Interim Efficacy
Amneal reported six-week interim data from the Phase 4 ELEVATE-PD study in 214 Parkinson's patients. Across all prior regimens, switching to CREXONT extended-release capsules increased daily 'Good On' time by 3.03 to 3.33 hours, reduced daily 'Off' time by 2.4 to 3.20 hours and improved MDS-UPDRS total scores by up to 14.6 points.
2. RYTARY Subgroup Findings
Among the 41 patients switching from RYTARY extended-release capsules, continuous 'Good On' intervals nearly doubled from 3.19 to 6.27 hours, and mean daily motor fluctuations dropped 42.8%, from 5.28 to 2.98 episodes per day. These results highlight CREXONT’s ability to deliver longer, uninterrupted symptom control.
3. Safety and Ongoing Follow-Up
Treatment-emergent adverse events were generally mild to moderate, led by dizziness (8.2%), falls (6.9%), nausea (6.5%) and dyskinesia (6.5%). With enrollment complete, participants will continue through a 12-month follow-up, and Amneal will present longer-term outcomes and patient-reported measures throughout 2026.
