Amneal reports positive interim results for CREXONT in Parkinson's study
Amneal Pharmaceuticals Inc. (NASDAQ: AMRX) announced interim results from its Phase 4 ELEVATE-PD study showing patients with Parkinson's disease experienced increased daily "Good On" time after switching to CREXONT, according to a company statement.
The study evaluated 111 patients after six weeks of treatment. Patients switching from immediate-release carbidopa/levodopa gained 3.40 additional hours of daily "Good On" time, while those switching from RYTARY gained 3.07 hours. Patients switching from immediate-release carbidopa/levodopa plus a COMT inhibitor gained 2.91 hours.
Among the 22 patients who switched from RYTARY, the mean duration of continuous "Good On" intervals increased from 3.45 hours at baseline to 6.58 hours at week six. Daily motor fluctuations decreased from 4.75 at baseline to 2.79 at week six in this subgroup.
The study also showed reductions in daily "Off" time across treatment groups, with decreases of 3.18 hours, 3.09 hours, and 2.90 hours for patients switching from immediate-release carbidopa/levodopa, immediate-release carbidopa/levodopa plus COMT inhibitor, and RYTARY, respectively.
The most common adverse events reported were dizziness (9.0%), nausea (7.2%), falls (7.2%), dyskinesia (4.5%), hallucination (3.6%), and headache (3.6%). The company stated these were generally mild to moderate and consistent with prior therapy.
CREXONT received FDA approval for treating Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism following carbon monoxide or manganese intoxication. The ELEVATE-PD study plans to enroll approximately 220 participants and follow them for 13-14 months.
