Supernus Pharmaceuticals FDA Accepts SPN-830 NDA Resubmission

By Tamara Parker • Monday, August 19 07:55 • Permanent Link

Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) recently announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the new drug application (NDA) for its apomorphine infusion device, SPN-830. The device is intended for the continuous treatment of motor fluctuations (off episodes) in Parkinson's disease (PD). The FDA has acknowledged the resubmission and set a user fee goal date (PDUFA date) of February 1, 2025, for review.

This development is significant for Supernus Pharmaceuticals, as it expands its diverse neuroscience portfolio, which already includes approved treatments for epilepsy, migraine, ADHD, hypomobility in PD, cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. The company is also actively developing a broad range of novel CNS product candidates, including potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.

This news demonstrates the company's continued focus on developing and commercializing products for the treatment of central nervous system (CNS) diseases, and the acceptance of the NDA resubmission marks a significant step forward in the regulatory process for SPN-830. As the PDUFA date approaches, stakeholders will be closely watching for further updates on the progress of this important treatment for PD patients experiencing motor fluctuations. Today the company's shares have moved 0.9% to a price of $34.55. If you want to know more, read the company's complete 8-K report here.

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