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# FDA Rejects Supernus NDA for Parkinson’s Drug
- URL: https://www.fdaweb.com/fda-rejects-supernus-nda-for-parkinsons-drug/
- Published: 2022-10-10T12:00:00.000Z
- Updated: 2026-09-14T18:02:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152930

FDA has issued Supernus Pharmaceuticals a complete response letter on its NDA for SPN-830 (apomorphine) infusion device for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease. The letter requests “additional information and analysis related to the infusion device and drug product across several areas of the NDA including, but not limited to, labeling, product quality and manufacturing, device performance and risk analysis,” the company says.

The agency also said that before an approval could be granted, inspections are needed because they could not be completed in a timely manner due to Covid-19 travel restrictions, according to Supernus. However, it notes that the letter did not request additional efficacy and safety clinical studies, adding that it will continue to work closely with FDA to address all concerns.

The submission was met with FDA skepticism when first filed in 2020\. At the time, the agency sent the company a refusal-to-file letter, saying the NDA was not sufficiently complete to permit a substantive review ([see story](https://www.fdaweb.com/supernus-talking-with-fda-on-two-submissions/)) and asking for certain documents and reports to be submitted in support of the application.

“SPN-830 remains a key priority for Supernus as there is a need to provide a minimally invasive therapy for PD patients who are experiencing motor fluctuations not adequately controlled with current treatment options,” the company says.