The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for BXCL501 (dexmedetomidine) for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.
BXCL501 is an investigational orally dissolving thin film formulation 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.
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 with BXCL501 included somnolence, dry mouth and dizziness.
“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, CEO 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.”
A Prescription Drug User Fee Act (PDUFA) target date of January 5, 2022 has been set for the application.
BioXcel Therapeutics announces FDA acceptance for filing of NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. [press release]. New Haven, CT: BioXcel Therapeutics, Inc.; May 19, 2021.