FDA Approves BioXcel's Igalmi - First Orally Dissolving Sublingual Film For Schizophrenia-Associated Agitation

The FDA has approved BioXcel Therapeutics Inc's BTAI Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

• Igalmi can be self-administrated by patients under the supervision of a healthcare provider. The company is prepared to launch Igalmi in the U.S. in Q2 of 2022.
• An estimated 7.3 million people in the U.S. are diagnosed with schizophrenia or bipolar disorders. Up to a quarter of these people experience agitation, with episodes that can occur 10 to 17 times annually, totaling up to 25 million agitation episodes for these two patient populations per year.
• Related: BioXcel BXCL701 Combo Therapy Shows Encouraging Response Rates In Prostate Cancer.
• The FDA approval of Igalmi is based on data from two Phase 3 trials.
• 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, showing statistically significant improvements from baseline.
• Igalmi demonstrated the onset of action as early as 20 minutes and a high response rate with both 120 mcg and 180 mcg doses in pivotal studies.
• Price Action: BTAI shares are up 18.7% at $23.60 during the premarket session on the last check Wednesday.