Amneal Pharmaceuticals Inc. (AMRX), a biopharmaceutical company, announced on Monday positive interim data from the Phase 4 ELEVATE-PD trial for CREXONT in treating Parkinson's disease at the 2026 American Academy of Neurology (AAN).
Parkinson's disease is a progressive neurodegenerative disorder, caused by the buildup of Lewy bodies in a region of the brain called the substantia nigra, responsible for producing the neurotransmitter dopamine. Characterized by slowness of movement and functionality (dyskinesia), and accompanied by episodes of rapid, uncontrollable tics (akathasia), the disease can cause significant morbidity and disability. Present treatments include administering precursor forms of dopamine, like levodopa.
CREXONT is an extended-release capsule containing carbidopa and levodopa and was approved by the FDA for the treatment of Parkinson's disease in August 2024.
The Phase 4 ELEVATE-PD trial is evaluating whether switching to CREXONT can reduce OFF time, improve symptom control, and enhance daily functioning in adults with Parkinson's disease who continue to have motor complications despite a stable levodopa regimen.
Interim data from 111 patients, announced yesterday, showed a meaningful increase in "Good On" times of up to 3.40 more hours, and a significant decrease in "Off" times of up to 3.18 fewer hours. Improvement in motor symptoms was also seen in patients on CREXONT, indicated by a decrease of up to 15.3 points on the motor disorders society unified Parkinson's disease rating scale (MDS UPDRS).
The ELEVATE-PD trial aims to recruit a total of 220 patients observed over 13-14 months, including 10 clinical visits.
AMRX closed Monday at $13.26, down 4.67%.
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