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BioXcel Therapeutics Provides Update on Recent Developments for Late-Stage Clinical Programs and Expansion of IP Portfolio for IGALMI™ (dexmedetomidine) Sublingual Film
Meetings scheduled with FDA in October and November for TRANQUILITY and SERENITY III programs Company strengthens IGALMI™ market exclusivity through receipt
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Meetings scheduled with FDA in October and November for TRANQUILITY and SERENITY III programs Company strengthens IGALMI™ market exclusivity through receipt of two Notices of Allowance NEW HAVEN, Conn., Oct. 04, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience, today provided an update on recent developments with its late-stage clinical programs as well as its patent portfolio for IGALMI™ (dexmedetomidine) sublingual film. These developments include meetings scheduled with the U.S. Food and Drug Administration (FDA) to discuss the TRANQUILITY and SERENITY III clinical programs and the receipt of two Notices of Allowance (NOAs) from the U.S. Patent and Trademark Office to extend method of use patent protection for sublingual dexmedetomidine. “We believe that we have a substantial body of clinical, non-clinical, and pharmacokinetic (PK) data to discuss with the FDA with the goal of gaining alignment on a potential package required for supplemental new drug application (sNDA) submissions,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “The meetings with the FDA are critical components of our business strategy. We plan to seek alignment on a path for the potential approval to expand the market for BXCL501 for the at-home and assisted living facility treatment of mild to moderate agitation associated with dementia due to Alzheimer’s disease, and for the at-home acute treatment of agitation associated with bipolar I and II disorders and schizophrenia. Expanding BXCL501 into these large, underserved markets, while advancing IGALMI™ commercialization, are our top priorities.” Late-Stage Clinical Programs: TRANQUILITY and SERENITY III Agitation Associated with Mild to Moderate Dementia due to Probable Alzheimer’s Disease (AAD): Type B/Breakthrough Meeting on October 11The Company plans to review its TRANQUILITY clinical trial program with the FDA and to discuss the data package required to support submission of an sNDA for the approval of BXC501 for the acute treatment of agitation in mild to moderate dementia patients with probable Alzheimer’s disease in assisted living facilities and at-home settings. The briefing book submitted to FDA for the meeting includes results from 11 double-bli...