Amneal's CREXONT Shows Significant Clinical Benefits in Phase 4 Parkinson's Disease Study
Key Insights
Interim results from the Phase 4 ELEVATE-PD study demonstrate that CREXONT (search) extended-release capsules significantly increased daily "Good On" time by up to 3.13 hours compared to other oral carbidopa/levodopa therapies.
The first 55 patients evaluated after six weeks showed substantial reductions in "Off" time and improved motor symptom control, with benefits observed regardless of previous treatment regimen.
CREXONT (search)'s novel mucoadhesive polymer technology provides the longest-lasting levodopa plasma levels of any oral carbidopa/levodopa therapy currently available.
Amneal Pharmaceuticals has announced positive interim results from its ongoing Phase 4 ELEVATE-PD study, demonstrating substantial clinical benefits for patients with Parkinson's disease (search) who switched to CREXONT (search) extended-release capsules. The findings, presented at the Parkinson's Study Group Annual Meeting, show significant improvements in motor symptom control and daily functioning compared to other oral carbidopa/levodopa therapies.
Substantial Improvements in Daily Function
The interim analysis of the first 55 patients evaluated after six weeks of treatment revealed remarkable improvements across multiple clinical measures. Patients experienced significant increases in daily "Good On" time, with gains of 3.13 hours when switching from immediate-release carbidopa/levodopa, 2.31 hours from immediate-release carbidopa/levodopa with a COMT inhibitor, and 1.80 hours from RYTARY extended-release capsules.
Corresponding reductions in daily "Off" time were equally impressive, with decreases of 2.83 hours, 2.36 hours, and 2.57 hours respectively across the three treatment groups. The study population had a mean age of 66.4 ± 8.95 years.
"These early results confirm what clinicians are already seeing every day—patients on CREXONT (search) feel better, stay 'On' longer, and experience more predictable control of their symptoms," said Stuart Isaacson, MD, Director of the Parkinson's Disease (search) and Movement Disorders Center in Boca Raton, FL.
Enhanced Motor Symptom Control
Beyond improvements in "On" and "Off" time, patients demonstrated significant gains in "Good On" time per dose, with increases of 1.86, 0.77, and 0.79 hours respectively across the three treatment groups. Motor symptom improvements were measured using the MDS-UPDRS total score, showing reductions of 14.2, 4.1, and 13.9 points respectively.
Dr. Avinash Desai, Senior Vice President and Chief Scientific Officer, Specialty, at Amneal Pharmaceuticals, emphasized the clinical significance: "These interim results reinforce what patients and providers are already experiencing: CREXONT (search) is measurably improving daily function and elevating care for people living with Parkinson's. In a field with limited innovation for decades, CREXONT is perhaps the most significant therapy advancement in decades."
Novel Formulation Technology
CREXONT (search) represents a next-generation extended-release carbidopa/levodopa formulation utilizing a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption. The innovative formulation consists of immediate-release granules with carbidopa and levodopa for rapid onset of action, combined with extended-release pellets containing the mucoadhesive polymer technology with a levodopa core for long-lasting efficacy.
This technology provides the longest-lasting levodopa plasma levels of any oral carbidopa/levodopa therapy available today, based on the time that levodopa plasma levels were maintained above 50% of Cmax.
Safety Profile and Ongoing Research
The safety profile observed in the study showed treatment-emergent adverse events that were generally mild to moderate and consistent with prior therapy. The most common adverse events (≥3%) included nausea (5.5%), falls (3.6%), dizziness (3.6%), and urinary tract infection (3.6%).
The ELEVATE-PD study is an open-label, Phase 4, multi-center clinical study designed to evaluate the real-world efficacy and safety of switching to CREXONT (search) in adults with moderately severe Parkinson's disease (search) experiencing motor complications. The trial plans to enroll approximately 220 participants and will follow them for 13-14 months across 10 clinical visits.
Amneal plans to present longer-term outcomes and patient-reported results in 2026 as part of the ongoing, rolling ELEVATE-PD program, which will further strengthen the evidence for CREXONT (search)'s impact on motor symptom control and functional independence.
Addressing Growing Medical Need
Parkinson's disease (search) has become the fastest growing neurological disorder worldwide, with approximately 1 million people diagnosed in the United States. It is a progressive disorder of the central nervous system that affects dopamine-producing neurons in the brain, characterized by slowness of movement, stiffness, resting tremor, and impaired balance. The average age at diagnosis is 60, and as people live longer, the number of people living with Parkinson's disease is predicted to grow significantly over the coming decades.