BioXcel Therapeutics has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for BXCL501 (dexmedetomidine) for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.

Dexmedetomidine is currently available as a solution for intravenous infusion for use in clinical anesthesia and sedation in an intensive care setting. BXCL501 is an investigational proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist.

The NDA submission is supported by data from the double-blind, placebo-controlled, parallel group phase 3 SERENITY I (ClinicalTrials.gov: NCT04268303) and II (ClinicalTrials.gov: NCT04276883) studies that evaluated the efficacy and safety of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively. Patients were randomly assigned 1:1:1 to receive either BXCL501 120mcg, 180mcg, or placebo. 

Results from both studies showed that BXCL501 met the primary end point achieving statistically significant and clinically meaningful reductions in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) score at 2 hours vs placebo (P <.0001). Additionally, both studies met key secondary end points including highly statistically significant improvements in PEC score with BXCL501 at 30 minutes, 45 minutes, 60 minutes and 90 minutes. The most common adverse events reported in both studies were somnolence, dry mouth and dizziness.


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“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,” said Vimal Mehta, CEO of BioXcel. “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 US market.”

Reference

BioXcel Therapeutics submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders. [press release]. New Haven, CT: BioXcel Therapeutics, Inc.; March 11, 2021.