Oral dexmedetomidine film screened for agitation with schizophrenia and bipolar disorder

The Food and Drug Administration (FDA) has approved the filing of the New Drug Application (NDA) for BXCL501 (dexmedetomidine) for the acute treatment of arousal associated with schizophrenia and bipolar disorder I and II.

BXCL501 is an orally dissolving thin-film formulation of dexmedetomidine, a selective alpha-2a receptor agonist. NDA filing is supported by data from the double-blind, placebo-controlled, parallel-group phase 3 studies SERENITY I (ClinicalTrials.gov: NCT04268303) and II (ClinicalTrials.gov: NCT04276883), which assess the efficacy and safety of BXCL501 for the study Acute treatment of arousal in connection with schizophrenia and bipolar disorder I and II was assessed.

The results of both studies indicated that BXCL501 met the primary endpoint and achieved statistically significant and clinically meaningful reductions in the PEC (Positive and Negative Syndrome Scale-Excitatory Component) score after 2 hours versus placebo (P <0.0001). In addition, both studies met key secondary endpoints, 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 were drowsiness, dry mouth and dizziness.

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“Submitting our NDA is an important milestone in our goal of providing a new treatment option for millions of patients with schizophrenia and bipolar disorder struggling with acute arousal,” said Vimal Mehta, CEO of BioXcel. “We believe that BXCL501, if approved, would provide a significant improvement in care and restless management in these patients, potentially reducing the burden on physicians and related caregivers.”

A target date of the Prescription Drug User Fee Act (PDUFA) of January 5, 2022 was set for the application.

reference

BioXcel Therapeutics Announces FDA Approval for NDA Filing for BXCL501 for the Acute Treatment of Restlessness Associated with Schizophrenia and Bipolar Disorders I and II. [press release]. New Haven, CT: BioXcel Therapeutics, Inc .; May 19, 2021.

This article originally appeared on MPR

Subjects:

Bipolar Disorder Neurobehavioral Disorders Schizophrenia Treatments