Supernus Pharmaceuticals announced this week that the FDA had issued a Complete Response Letter for the New Drug Application resubmission of its Parkinson’s disease drug candidate, SPN-830.
The Maryland-based biopharma first submitted its NDA in September of 2020 and quickly received a refusal to file letter for the apomorphine infusion pump in November of the same year. In its letter, the FDA determined that the application was not sufficiently complete to permit a substantive review.
Two years later, Supernus is in a similar position. The CRL is asking the company to provide additional information and analysis related to the device and drug product in areas like labeling, product quality and manufacturing, device performance, and risk analysis. However, the FDA is not requiring any additional efficacy and safety clinical studies.
The drug uses an infusion device to continuously deliver apomorphine to the brain, a chemical compound that acts as a dopamine dupe.