Business
Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients
ROCKVILLE, Md., Feb. 08, 2021 (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., Feb. 08, 2021 (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 SPN-812 for the treatment of ADHD in pediatric patients. The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the NDA in November 2020 indicating that the review cycle for the application was incomplete and that the application was not ready for approval in its present form. Supernus and the FDA held a Type A meeting in January 2021 to discuss the CRL and the requirements for the NDA resubmission. The primary issue cited in the SPN-812 CRL relates to the Company’s in-house laboratory that conducts analytical testing, which recently moved to a new location. In the NDA resubmission Supernus removed reference to its in-house laboratory and addressed other contents of the CRL. The FDA will classify the NDA resubmission as Class I or Class II upon acceptance of the resubmission. Generally, a Class I review constitutes a two-month review from the date of resubmission and a Class II review constitutes a six-month review from the date of resubmission. In December 2020, Supernus announced positive results from a Phase III study for SPN-812 in adults with ADHD. The Company plans to submit a supplemental NDA to the FDA for SPN-812 in adults in the second half of 2021, assuming approval for pediatric patients. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals, Inc. 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, hypomobility in Parkinson’s Disease, cervical dystonia and chronic sialorrhea. We are committed to developing a broad range of novel CNS product candidates to address high unmet medical needs. Our development programs include new potential treatments for attention-deficit hyperactivity disorder, hypomobility in Parkinson’s Disease, epilepsy, depression, and rare CNS disorders. For more information, please visit https://www.supernus.com/. Forward-Looking Statements This press release includes forward-lo...