regulatory
confidence high
sentiment positive
materiality 0.75
Supernus receives FDA approval for ONAPGO as first subcutaneous apomorphine infusion device for Parkinson's
SUPERNUS PHARMACEUTICALS, INC.
- ONAPGO approved for continuous treatment of motor fluctuations in advanced Parkinson's patients not controlled by oral levodopa.
- Phase 3 study: ONAPGO reduced daily OFF time by 2.6 hours vs 0.9 hours placebo (p=0.0114); GOOD ON time increased 2.8 vs 1.1 hours.
- Product will be available in the U.S. in Q2 2025, with a support team including nurse education programs.
- Most common adverse events (≥10%): infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, insomnia.
- CEO Jack Khattar stated ONAPGO demonstrates Supernus' continued commitment to CNS innovation.