Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) has provided a regulatory update for its investigational apomorphine infusion device, SPN-830, aimed at treating motor fluctuations in Parkinson's disease (PD). The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to the new drug application (NDA) for SPN-830, indicating 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. The first area relates to product quality, for which the company has recently submitted additional data to the FDA. The second area pertains to the master file for the infusion device, which is proprietary to the device manufacturer. The FDA's preapproval inspection of the device manufacturer's facility in February 2024 was successful, with no clinical safety or efficacy issues identified as a requirement for approval.
Supernus Pharmaceuticals remains committed to bringing SPN-830 to the market and plans to work with the FDA to address the CRL and successfully resubmit the NDA for SPN-830.
Supernus Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Their diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in PD, cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. The company is also developing a broad range of novel CNS product candidates, including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. The market has reacted to these announcements by moving the company's shares -5.2% to a price of $31.8. For the full picture, make sure to review Supernus Pharmaceuticals's 8-K report.
