regulatory
confidence high
sentiment neutral
materiality 0.70
Supernus resubmits NDA for SPN-830 apomorphine infusion for Parkinson's OFF episodes
SUPERNUS PHARMACEUTICALS, INC.
- Resubmitted NDA for SPN-830 (apomorphine infusion device) to FDA for continuous treatment of OFF episodes in Parkinson's disease.
- CRL in April 2024 identified two areas needing additional info; no clinical safety or efficacy issues were raised.
- Company believes it has fully addressed the FDA's questions from the CRL.
- If approved, SPN-830 could be an important novel therapy for Parkinson's patients.
- Supernus will continue to work closely with the FDA during the NDA review process.