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Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device
ROCKVILLE, Md., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and
About this update from Supernus Pharmaceuticals, Inc.
[{"type":"text","content":"ROCKVILLE, Md., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD). Supernus believes it has addressed the U.S. Food and Drug Administration’s (FDA) questions related to a Complete Response Letter (CRL) issued in April 2024 for the SPN-830 NDA. The CRL had indicated that the review cycle for the application was complete, but that two areas either required additional review by the FDA or additional information to be provided to the FDA. No clinical safety or efficacy issues were identified at that time as a requirement for approval. Supernus will continue to work closely with the FDA as it reviews the SPN-830 NDA. “We continue to show our commitment to bring SPN-830 to the market and will support the FDA throughout the NDA review process,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “If approved, we believe this novel therapy can be an important treatment option for PD patients and their families.” About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson's disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actua...