공시 • Jun 05
Amneal Pharmaceuticals Announces Interim Phase 4 ELEVATE-PD Results For CREXONT In Parkinson's Disease
Amneal Pharmaceuticals, Inc. announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, which are being presented at the Advanced Therapeutics in Movement & Related Disorders 2026 Congress on June 5, 2026. 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%). Overall Interim Findings (Entire Study Population, 214 Patients; Six-Week Analysis): All 214 patients who switched to CREXONT (mean age 67.1±9.07 years): Increased Daily “Good On” Time: +3.33 hours when switching from IR CD/LD (n=156), +3.20 hours when switching from IR CD/LD + COMT inhibitor (n=17), +3.03 hours when switching from RYTARY (n=41). Reduced Daily “Off” Time: –3.20 hours when switching from IR CD/LD, –2.96 hours when switching from IR CD/LD + COMT inhibitor, –2.4 hours when switching from RYTARY. Improved MDS-UPDRS Total Scores: Improvements of –14.6, –9.9, and –10.0 points when switching from IR CD/LD, IR CD/LD + COMT inhibitor, and RYTARY, respectively — reductions of this magnitude reflect clinically meaningful gains in overall motor function. Subgroup Analysis: Additional Interim Findings in Patients Switching from RYTARY: Among the 41 patients switching from RYTARY, CREXONT delivered particularly notable gains in symptom control: Mean duration of continuous “Good On” intervals nearly doubled, increasing from 3.19 hours at baseline to 6.27 hours at Week 6, a 3.08-hour gain in uninterrupted symptom control. Mean daily motor fluctuations were meaningfully reduced, decreasing from 5.28 at baseline to 2.98 at Week 6, a 2.26 (42.80%) reduction in the average number of daily motor fluctuations. Safety: In the study, treatment-emergent adverse events (TEAEs) were generally mild to moderate and consistent with prior therapy. The most common (=3%) in the study were dizziness (8.2%), fall (6.9%), nausea (6.5%), dyskinesia (6.5%), hallucination (3.0%), and headache (3.0%). CREXONT should not be taken with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors. CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Treatment with carbidopa/levodopa, including CREXONT, may contribute to reduced vitamin B6 levels. Seizures associated with vitamin B6 deficiency have been reported. Evaluate vitamin B6 levels before and during treatment with carbidopa/levodopa therapies. CREXONT is Amneal’s next-generation extended-release carbidopa/levodopa (CD/LD) formulation that uses a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption, providing the longest-lasting levodopa plasma levels of any oral CD/LD therapy available. In May 2026, the FDA approved a labeling update providing an additional administration option for patients who have difficulty swallowing intact capsules, who may now take CREXONT by carefully opening and sprinkling the capsule contents on a small amount of applesauce, which should be immediately consumed. With enrollment in ELEVATE-PD now complete and patients continuing through the 12-month follow-up period, Amneal will present longer-term outcomes and patient-reported results throughout 2026, building a comprehensive body of evidence for CREXONT’s impact on motor symptom control and functional independence for people living with Parkinson’s disease.