Dexmedetomidine sublingual film meets primary and secondary endpoints in two phase 3 trials evaluating acute treatment of agitation in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II)

Studies demonstrated statistically significant reductions in Positive and Negative Syndrome Scale, Excitatory Component (“PEC”) score at 2 hours, the primary endpoint, for both high and low dose cohorts of dexmedetomidine vs. placebo (p<0.0001). Submission to FDA planned for 2021


Biospace Inc.