Benzinga | May 19, 2021 07:03AM EDT

BioXcel Therapeutics Announces FDA Acceptance For Filing Of NDA For BXCL501 For Acute Treatment Of Agitation Associated With Schizophrenia And Bipolar Disorders I And II

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 U.S. Food and Drug Administration ("FDA") has accepted for filing the New Drug Application ("NDA") for BXCL501, the Company's proprietary, investigational, orally dissolving thin film formulation of dexmedetomidine, for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of January 5, 2022. At this time, the FDA is not planning to hold an advisory committee meeting to discuss the application.

"The filing of our NDA marks an important milestone toward our goal to provide a new treatment option for the millions of patients with schizophrenia and bipolar disorders struggling with acute agitation," said Vimal Mehta, Chief Executive Officer of BioXcel. "We believe that BXCL501, if approved, would represent a significant improvement in the care and management of agitation in these patients, potentially easing the burden for physicians and allied caregivers. While the FDA reviews our application, we will continue to execute on our comprehensive commercial strategy to ensure we are well positioned for potentially bringing BXCL501 -- which is designed to address an important unmet need -- to both patients and health care providers across the U.S."

The application 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 trials, BXCL501 was well-tolerated and met the primary and secondary endpoints at the 120 mcg and 180 mcg doses, demonstrating statistically significant, rapid and durable improvements from baseline versus placebo across multiple agitation scales.