BioXcel Therapeutics has announced the FDA approval of Igalmi, a sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Igalmi (dexmedetomidine), which can be self-administered by patients under the supervision of a health care provider, is the first and only FDA-approved orally dissolving sublingual film for this indication, the company said in a press release. It will be available in the U.S. in the second quarter of 2022.
The FDA approval is based on data from two randomized, double-blind, placebo-controlled, parallel group phase