Supernus: FDA says SPN-830 NDA ‘not ready for approval’ in present form

Supernus Pharmaceuticals announced a regulatory update for SPN-830. SPN-830 is an investigational apomorphine infusion device for the continuous treatment of motor fluctuations in Parkinson’s disease under U.S. Food and Drug Administration review. The FDA has issued a Complete Response Letter in response to the Company’s New Drug Application for SPN-830. The CRL indicates that the review cycle for the application is complete, but that the application is not ready for approval in its present form. The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA. The first area relates to product quality. The Company recently submitted additional product quality data to the FDA which it has not yet reviewed. The second relates to the master file for the infusion device which is proprietary to the device manufacturer. The Company plans to discuss with the device manufacturer the provision of the requested information and the steps required for the resubmission of the NDA for SPN-830. No clinical safety or efficacy issues were identified as a requirement for approval. The FDA completed in February 2024 a successful preapproval inspection of the device manufacturer’s facility.