BXCL501, a Promising Fast-Acting Therapy for Acute Agitation in Alzheimer Disease: George Grossberg, MD


The director of Geriatric Psychiatry at the St Louis University School of Medicine talked about an oral film form of BXCL501, an alternative to intravenously administered therapies that shows promise in rapidly alleviating acute agitation in patients with Alzheimer disease. [WATCH TIME: 7 minutes]

WATCH TIME: 7 minutes

"BXCL501 is an exciting development because it's an acute drug that works within minutes, offering a new option for managing acute agitation in patients with Alzheimer disease. The therapy’s potential as a PRN medication for acute agitation, even in overtly aggressive cases, could significantly improve the quality of care for these patients."

BXCL501 (Igalmi; BioXcel Therapeutics) is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, which is a selective alpha-2 adrenergic receptor agonist. Currently, the therapy is under investigation for the acute treatment of Alzheimer disease (AD)-related agitation as well as other conditions. To date, it has been granted breakthrough therapy and fast track designation for acute treatment of agitation associated with dementia.

Recently announced positive topline results from the phase 3 TRANQUILITY II trial (NCT05271552) assessing BXCL501 showed that the agent met its primary efficacy end point.1 In the trial, investigators observed a statistically significant and clinically meaningful 7.5-point reduction from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at 2 hours with 60 mcg dose of BXCL501 versus a 5.4 reduction with placebo (P = .0112). The same dosage met the first key secondary end point of reducing agitation symptoms at 1 hour during the first episode of agitation (P = .0185); however, it did not meet the other key secondary end point of change from baseline in PEC score at 30 minutes.

George Grossberg, MD, Samuel W. Fordyce professor and director, Geriatric Psychiatry, St Louis University School of Medicine, sat down in a recent interview with NeurologyLive® to discuss how the therapy differs from other existing treatments in addressing acute agitation among patients with AD. He talked about the key implications of BXCL501's rapid action for healthcare providers and the families caring for patients with this condition. In addition, Grossberg spoke about how BXCL501 can be administered by family members at home, and the steps that are being taken to make this possible.

1. BioXcel Therapeutics Announces Positive Topline Results From TRANQUILITY II Phase 3 Trial of BXCL501 for Acute Treatment of Alzheimer’s Disease-Related Agitation. News Release. BioXcel Therapeutics. Published June 29, 2023. Accessed October 6, 2023. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-positive-topline-results
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