Amneal Pharmaceuticals Inc. (NASDAQ: AMRX) announced interim results from its Phase 4 ELEVATE-PD study showing clinical benefits for patients with Parkinson's disease who switched to CREXONT, the company's extended-release carbidopa and levodopa treatment.

The study evaluated 214 patients after six weeks of treatment. Patients who switched from immediate-release carbidopa/levodopa gained 3.33 hours of additional daily "Good On" time and reduced "Off" time by 3.20 hours. Those switching from immediate-release carbidopa/levodopa plus a COMT inhibitor gained 3.20 hours of "Good On" time and reduced "Off" time by 2.96 hours.

Patients switching from RYTARY, a competing extended-release treatment, gained 3.03 hours of daily "Good On" time and reduced "Off" time by 2.4 hours. The duration of continuous "Good On" intervals nearly doubled from 3.19 hours to 6.27 hours among the 41 patients switching from RYTARY.

All treatment groups showed improvements in MDS-UPDRS total scores, with reductions of 14.6, 9.9, and 10.0 points 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 (8.2%), falls (6.9%), nausea (6.5%), dyskinesia (6.5%), hallucination (3.0%), and headache (3.0%).

The results were presented at the Advanced Therapeutics in Movement & Related Disorders Congress. CREXONT received FDA approval with a formulation that uses mucoadhesive polymer technology designed to extend levodopa delivery. The ELEVATE-PD study has completed enrollment of 232 participants who are continuing through a 12-month follow-up period.