CREXONT Shows Superior Efficacy in Phase 4 Trial, Delivering Over 3 Additional Hours of Daily "Good On" Time for Parkinson's Patients
核心洞察
Amneal's Phase 4 ELEVATE-PD trial demonstrated that CREXONT (搜索) provided clinically meaningful benefits across all prior treatment groups, with patients gaining 2.91 to 3.40 hours of additional daily "Good On" time after switching from various carbidopa/levodopa therapies.
Patients switching from RYTARY to CREXONT (搜索) experienced particularly notable improvements, with continuous "Good On" intervals nearly doubling from 3.45 hours to 6.58 hours and daily motor fluctuations reducing by 1.92 episodes.
The interim safety profile showed treatment-emergent adverse events were generally mild to moderate, with the most common being dizziness (9.0%), nausea (7.2%), and falls (7.2%).
Amneal Pharmaceuticals announced positive interim results from its Phase 4 ELEVATE-PD study, demonstrating that CREXONT (搜索) (carbidopa and levodopa) extended-release capsules delivered substantial clinical benefits for Parkinson's disease (搜索) patients. The first 111 patients evaluated after six weeks of treatment showed meaningful improvements in motor symptom control, regardless of their previous therapy regimen.
Significant Gains in Daily Symptom Control
The interim data revealed consistent increases in daily "Good On" time across all treatment groups. Patients switching from immediate-release carbidopa/levodopa (IR CD/LD) gained 3.40 hours of additional daily "Good On" time, while those transitioning from IR CD/LD plus a COMT inhibitor experienced a 2.91-hour increase. Patients switching from RYTARY achieved a 3.07-hour gain in daily "Good On" time.
Corresponding reductions in daily "Off" time were observed across all groups: 3.18 hours for patients switching from IR CD/LD, 3.09 hours for those transitioning from IR CD/LD plus COMT inhibitor, and 2.90 hours for patients switching from RYTARY.
Enhanced Motor Function and Continuous Symptom Control
Motor function improvements were measured using MDS-UPDRS Total Scores, with reductions of 15.3, 10.0, and 10.3 points when switching from IR CD/LD, IR CD/LD plus COMT inhibitor, and RYTARY, respectively. According to the study investigators, reductions of this magnitude reflect clinically meaningful gains in overall motor function.
Among the 22 patients switching from RYTARY, CREXONT (搜索) demonstrated particularly notable benefits. The mean duration of continuous "Good On" intervals nearly doubled, increasing from 3.45 hours at baseline to 6.58 hours at Week 6, representing a 3.09-hour gain in uninterrupted symptom control. Additionally, mean daily motor fluctuations decreased from 4.75 at baseline to 2.79 at Week 6, a reduction of 1.92 daily motor fluctuations.
Safety Profile and Clinical Perspective
Treatment-emergent adverse events were generally mild to moderate and consistent with prior therapy. The most common adverse events (≥3%) included dizziness (9.0%), nausea (7.2%), falls (7.2%), dyskinesia (4.5%), hallucination (3.6%), and headache (3.6%).
"In the absence of a cure for Parkinson's, our goal as clinicians is to help patients better manage their symptoms and preserve quality of life for as long as possible," said Dr. Robert Hauser, MD, a study investigator and Professor of Neurology at the Parkinson's Disease (搜索) and Movement Disorders Center, University of South Florida. "These encouraging interim results underscore the real-world impact CREXONT (搜索) can have in giving patients more 'Good On' time with fewer dosing interruptions throughout their day-to-day."
Novel Formulation Technology
CREXONT (搜索) represents Amneal's next-generation extended-release carbidopa/levodopa formulation, utilizing a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption. The therapy provides the longest-lasting levodopa plasma levels of any oral carbidopa/levodopa therapy available today.
The formulation consists of immediate-release granules with carbidopa and levodopa for rapid onset of action and extended-release pellets containing mucoadhesive polymer technology with a levodopa core for long-lasting efficacy. This design differs from RYTARY, which was approved by the FDA in 2015.
Study Design and Future Plans
ELEVATE-PD is an open-label, Phase 4, multi-center clinical study designed to evaluate the real-world efficacy and safety of switching to CREXONT (搜索) in adults with Parkinson's disease (搜索) experiencing motor complications. The trial plans to enroll approximately 220 participants and will follow them for 13-14 months across 10 clinical visits.
Dr. Avinash Desai, Senior Vice President and Chief Scientific Officer, Specialty, at Amneal, noted that "when we assess what patients value most in their Parkinson's disease (搜索) treatment, longer periods of 'Good On' time and less burdensome dosing schedules are among the most important priorities. These interim results confirm that CREXONT (搜索) delivers on that need."
As the study continues enrollment, Amneal plans to present longer-term outcomes and patient-reported results throughout 2026, building a comprehensive evidence base for CREXONT (搜索)'s impact on motor symptom control and functional independence for people living with Parkinson's disease (搜索).