Drug for the Treatment of Agitation Moves Closer to Reality

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The US Food and Drug Administration (FDA) has accepted for filing BioXcel Therapeutics’s New Drug Application (NDA) for BXCL501 for the treatment of agitation associated with schizophrenia and bipolar disorders I and II.

“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, PhD, 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.”¹

BXCL501 is an orally dissolving, thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms.

The application is supported by data from 2 randomized, double-blinded, placebo-controlled, parallel group phase 3 studies, SERENITY I & SERENITY II. SERENITY I studied, agitation associated with schizophrenia, while SERENITY II sought to understand agitation associated with bipolar disorders I and II. In both trials, BXCL501 was well-tolerated and met the primary and secondary endpoints at the 120 mcg and 180 mcg doses. Both trials also demonstrated statistically significant, rapid improvements from baseline versus placebo across multiple agitation scales.

“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 US,” said Mehta.¹

The FDA has assigned a Prescription Drug User Fee Act 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.

Reference

1. BioXcel Therapeutics. 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. May 19, 2021. https://www.biospace.com/article/releases/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/