FDA Closes Inspection of BioXcel’s TRANQUILITY II Trial Site, Reinforcing Data Integrity

BioXcel Therapeutics (BTAI) announced that the U.S. Food and Drug Administration (FDA) has officially closed its inspection of a single site involved in the TRANQUILITY II Phase 3 trial under 21 C.F.R.20.64(d)(3). The FDA’s designation of “Voluntary Action Indicated” (VAI) signals that while minor issues may have been identified, no regulatory action is required, further supporting the reliability of the trial’s data.

BioXcel CEO Vimal Mehta, Ph.D., emphasized the significance of this development, stating, “This report and the closing of the investigation, alongside our independent audit findings from October 2023, reaffirm the integrity of our clinical data. With FDA feedback already received on our TRANQUILITY In-Care Phase 3 trial protocol, we are eager to advance this program with our lead neuroscience asset, BXCL501.”

BXCL501, a proprietary, orally dissolving film formulation of dexmedetomidine, is being investigated for the acute treatment of agitation associated with Alzheimer’s dementia, bipolar disorder, and schizophrenia in at-home settings. The drug has already received Breakthrough Therapy designation for dementia-related agitation and Fast Track designation for agitation associated with schizophrenia, bipolar disorders, and dementia.

With the TRANQUILITY II site inspection now closed, BioXcel remains focused on progressing its late-stage trials and preparing for a potential supplemental New Drug Application (sNDA) submission, positioning BXCL501 as a key player in the treatment of neuropsychiatric agitation.

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