Supernus resubmits NDA for SPN-830 with FDA

13 October 2023

USA-based CNS disease specialist Supernus Pharmaceuticals (Nasdaq: SUPN) has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).

Working closely with the US Food and Drug Administration (FDA), Supernus said it believes it has addressed the agency’s questions related to a complete response letter (CRL) issued in October 2022 for the SPN-830 NDA.

The CRL required additional information and analysis related to the infusion device and drug product across several areas of the NDA. In addition, the FDA mentioned at the time that approval of the NDA required inspections that could not be completed in a timely manner due to COVID-19 travel restrictions. The CRL did not request additional efficacy and safety clinical studies. Supernus will continue to work closely with the FDA as it reviews the SPN-830 NDA.

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