BioXcel Therapeutics (NASDAQ:BTAI) initiates SERENITY (Sub-Lingual DExmedetomidine in Agitation Associated With Schizophrenia and Bipolar Disorder Study) program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. Topline data from both Phase 3 trials are expected in mid-2020.
The studies will enroll up to 750 patients 18 to 75 years of age. The primary endpoint is reducing acute agitation measured by the Positive and Negative Syndrome Scale, examining the Excited Component (“PEC”) change from baseline compared to placebo.
A key secondary endpoint includes determining the earliest time where an effect on agitation is apparent as measured by the change from baseline in PEC total score.
BXCL501 is a sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation.
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