BioXcel Therapeutics’ (NASDAQ:BTAI) BXCL501, a dexmedetomidine sublingual thin film, met its primary and secondary endpoints in two Phase 3 trials in patients with schizophrenia and bipolar disorders.
In the SERENITY I and SERENITY II studies, patients with agitation associated with schizophrenia or bipolar disorders were randomized to receive BXCL501 at 120 micrograms, BXCL501 at 180 micrograms, or matching placebo.
Both studies met the primary endpoint of a statistically significant reduction in acute agitation change from baseline, compared with placebo, as measured by the positive and negative syndrome scale – excitatory component (PEC).
Both studies also met the key secondary endpoint of improvement in PEC scores beginning as early as 20 minutes in patients with bipolar disorder, at both dose levels, and as early as 20 minutes in patients with schizophrenia at the 180 microgram dose level.
“These compelling Phase 3 results show that BXCL501, if approved, has the potential to become an important new treatment option for patients suffering from acute agitation,” Vimal Mehta, BioXcel’s CEO, said in a statement.
“We believe these results suggest that BXCL501 may have potential to treat agitation across a wide range of conditions. As we initiate steps toward regulatory submissions in these first two indications, we are also rapidly advancing the investigation of BXCL501 in additional disorders with significant unmet medical need, including dementia, hyperactive delirium and opioid withdrawal symptoms,” he added.
