The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to BXCL501 (dexmedetomidine; BioXcel Therapeutics) for the acute remedy of agitation related to dementia.
Dexmedetomidine is at the moment accessible as an answer for intravenous infusion for use in scientific anesthesia and sedation in an intensive care setting. BXCL501 is an investigational oral skinny movie formulation of dexmedetomidine, a selective alpha-2a receptor agonist.
The designation is supported by knowledge from the randomized, double-blind, placebo-controlled section 1b/2 TRANQUILITY research (ClinicalTrials.gov: NCT04251910), which evaluated the efficacy, security and pharmacokinetics of BXCL501 in 54 sufferers aged 65 years and older with acute agitation related to dementia; 87% of research members had Alzheimer illness. Patients have been randomly assigned to obtain BXCL501 30mcg (n=16), 60mcg (n=20), 90mcg (n=4) or placebo (n=14).
Results confirmed statistically vital reductions in agitation measures (Positive and Negative Syndrome Scale-Excitatory Component; Pittsburgh Agitation Scale; and Modified Cohen-Mansfield Agitation Inventory) at 2 hours post-dose with the 30mcg and 60mcg doses in contrast with placebo. The most typical antagonistic occasion reported was somnolence which was delicate or reasonable in severity.
“Managing dementia associated agitation, particularly in aged sufferers, represents a major problem for physicians and caregivers, as there are at the moment no FDA-approved therapies and off-label medication include black field warnings,” mentioned Vimal Mehta, Chief Executive Officer of BioXcel. “The FDA’s determination to grant Breakthrough Therapy designation additional underscores the numerous unmet want for a brand new remedy for this underserved affected person inhabitants, in addition to highlights BXCL501’s potential in turning into the primary therapeutic possibility, if authorized, to handle this debilitating medical situation.”
The Company additionally recently submitted a New Drug Application for BXCL501 to deal with agitation related to schizophrenia and bipolar issues I and II.
- BioXcel Therapeutics receives FDA Breakthrough Therapy designation for BXCL501 for the acute remedy of agitation related to dementia. [press release]. New Haven, CT: BioXcel Therapeutics, Inc.; March 15, 2021.
- BioXcel Therapeutics pronounces BXCL501 met the first and all secondary endpoints within the TRANQUILITY section 1b/2 research for the acute remedy of agitation in dementia, together with Alzheimer’s illness. [press release]. New Haven, CT: BioXcel Therapeutics, Inc.; January 5, 2021.