IvelinRadkov/iStock via Getty Images
- Supernus Pharmaceuticals (NASDAQ:SUPN) is trading 12.6% down premarket after the U.S. Food and drug Administration declined to approve its apomorphine infusion device, SPN-830, to treat motor fluctuations in Parkinson’s disease.
- The FDA has asked the company for additional information and analysis related to the infusion device and drug product, including labeling, product quality and manufacturing, device performance and risk analysis.
- The FDA also mentioned that approval of the marketing application also required inspections that could not be completed in a timely manner due to COVID-19 travel restrictions.
- Supernus said it will continue to work closely with the FDA to address all questions, and provide clarity regarding the potential timing of a resubmission of the NDA (New Drug Application)
- The Company’s application in response to the CRL will now be subject to a Class 2, or six-month, review timeline..