Supernus resubmits NDA for SPN-830 apomorphine infusion device

Supernus Pharmaceuticals announced it has resubmitted its New Drug Application for its apomorphine infusion device for the continuous treatment of motor fluctuations in Parkinson’s disease. Working closely with the U.S. Food and Drug Administration, Supernus believes it has addressed the FDA’s questions related to a Complete Response Letter issued in October 2022 for the SPN-830 New Drug Application. 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. “SPN-830 represents a novel and less invasive therapy approach for PD patients who are seeking a convenient option in the form of a continuous subcutaneous infusion of apomorphine,” said Jack Khattar, President and CEO of Supernus. “We look forward to continuing our effort with the FDA throughout the NDA review process to bring a promising alternative to patients and their families.”