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BioXcel Therapeutics Announces Extension of FDA Review Period of its NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
PDUFA date extended by three months to April 5, 2022 No Additional Data Requested Following Meeting with FDA NEW HAVEN, Conn., Dec. 01, 2021 (GLOBE NEWSWIRE)
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"PDUFA date extended by three months to April 5, 2022 No Additional Data Requested Following Meeting with FDA NEW HAVEN, Conn., Dec. 01, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. In connection with the FDA’s ongoing review, BioXcel Therapeutics responded to the agency’s information request pertaining to analyses of clinical data, and was recently informed the application would require additional time for review. As a result, the FDA extended the previously disclosed PDUFA date of January 5, 2022 to April 5, 2022. BioXcel Therapeutics and the FDA met on November 30. No additional data has been requested. “Following our meeting with the FDA, we remain committed to working closely with the agency to facilitate a review of our NDA for BXCL501 and excited about making this potential therapy available to patients and caregivers as soon as possible,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “As we prepare for anticipated FDA approval, we are confident in BXCL501’s broad potential to treat the millions of patients suffering from agitation associated with schizophrenia and bipolar disorders.” About BXCL501 BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation associated with neuropsychiatric disorders. BioXcel believes that BXCL501 potentially targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders, including schizophrenia related agitation (SERENITY I), bipolar disorder related agitation (SERENITY II) and dementia related agitation (TRANQUILITY). BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with...