FX.co ★ FDA To Review Supernus Pharma' NDA For SPN-830 Apomorphine Infusion Device

Supernus Pharmaceuticals Inc. (SUPN) announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for SPN-830, an apomorphine infusion device aimed at the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease.

This resubmission is now officially filed, with a Prescription Drug User Fee Act (PDUFA) target date set for February 1, 2025.

In October 2022, the FDA initially declined to approve SPN-830 for the continuous treatment of motor fluctuations in Parkinson's disease, citing the need for additional data and analysis related to various aspects of the infusion device and drug, including labeling, product quality, manufacturing, device performance, and risk analysis.

Notably, the FDA did not request any further efficacy and safety clinical studies at that time.