BioXcel Therapeutics : FDA Approves IGALMI Sublingual Film

(RTTNews) - BioXcel Therapeutics Inc. (BTAI) said that the U.S. Food and Drug Administration has approved IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

The company noted that IGALMI can be self-administrated by patients under the supervision of a healthcare provider.

The company plans to launch IGALMI in the U.S. in the second quarter of 2022.

The FDA approval of IGALMI is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group Phase 3 trials evaluating IGALMI for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).

In both trials, IGALMI met the primary endpoint at two hours after the first dose in patients treated with the 120 mcg and 180 mcg doses, demonstrating statistically significant improvements from baseline.

IGALMI also met the key secondary endpoint, demonstrating a rapid onset of action, with statistically significant separation from placebo observed at 20 minutes for both the 180 mcg and 120 mcg doses in SERENITY II and 20 minutes and 30 minutes in SERENITY I, respectively.