BRIDGEWATER, N.J. – Amneal Pharmaceuticals announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, which wer presented at the Advanced Therapeutics in Movement & Related Disorders (ATRMD) 2026 Congress last week.
The entire study population (n=214) evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to CREXONT (carbidopa and levodopa) extended-release capsules, regardless of whether patients switched from immediate-release carbidopa/levodopa (IR CD/LD), IR CD/LD plus a COMT inhibitor, or RYTARY (carbidopa and levodopa) extended-release capsules. These interim findings build on the established efficacy and safety profile of CREXONT demonstrated in the Phase 3 RISE-PD trial, and reflected in the FDA-approved prescribing information.
After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in “Good On” time, reductions in “Off” time, and improved motor symptom control. Patients switching from RYTARY achieved consistent gains in continuous “Good On” intervals, the length of uninterrupted time patients experience “Good On.”
The most common adverse events (≥3%) in the study were dizziness (8.2%), fall (6.9%), nausea (6.5%), dyskinesia (6.5%), hallucination (3.0%), and headache (3.0%).
“The results from the entire study population highlight the consistency of CREXONT in delivering meaningful benefit to patients, regardless of the therapy they had been using,” said Dr. Stuart Isaacson, a Study Investigator and Director of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, FL. “This kind of reproducible, real-world signal is what gives us confidence as clinicians that patients will experience more “Good On” time and less interruptions to their daily lives.”
“Consistent with the previously reported results, the interim data from the entire study population of ELEVATE-PD underscores CREXONT ability to give patients more predictable symptoms control,” added Dr. Avinash Desai, Senior Vice President and Chief Scientific Officer, Specialty, at Amneal. “We believe these results further support CREXONT as a differentiated extended-release oral therapy, giving patients longer continuous “Good On” time per day.”
