Benzinga | Mar 11, 2021 07:11AM EST

BioXcel Therapeutics Submits New Drug Application to FDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders

BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the Company has completed the rolling submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. BXCL501 is the Company's proprietary, investigational, orally dissolving thin film formulation of dexmedetomidine ("Dex"). The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

"This submission is a significant achievement for BioXcel, having taken this program from its first-in-human trial to NDA submission in just over 2 years," commented Vimal Mehta, Chief Executive Officer of BioXcel. "BXCL501 was discovered using our innovative AI platform and we believe, if approved, could provide health professionals and patients with a fast acting, orally dissolving treatment option. We look forward to hearing back from the FDA and continuing with our commercial preparations to potentially bring a novel product that is designed to treat agitation associated with schizophrenia and bipolar disorders I and II to the U.S. market."

The submission is supported by data from two randomized, double-blinded, placebo-controlled, parallel group Phase 3 studies (SERENITY I & SERENITY II) of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively. In both studies, BXCL501 was well tolerated and met the primary and secondary endpoints at the 120 mcg and 180 mcg doses, showing statistical significance versus placebo in mean change across multiple agitation scales.