(BioXcel) Shares of BioXcel Therapeutics rose more than 24% in premarket on Tuesday after saying its treatment course for Bipolar I and II disorders in adults was approved by FDA.
BioXcel said that the FDA approved IGALMI™ or dexmedetomidine, a sublingual film for the acute treatment of complications associated with the disorders.
The company said that IGALMI™ can be self-administered by patients under the supervision of qualified healthcare personnel.
BioXcel found that IGALMI™ acted as early as 20 minutes, with a high response rate with both 120 mcg and 180 mcg dosages.
The biopharmaceutical firm said it is preparing to launch IGALMI™ in the US in the second half of this year.
The nod means that BioXcel becomes the first company with FDA-approved orally dissolving sublingual film for mild, moderate, and severe agitation from Schizophrenia or bipolar I or II disorder.
About 7.3 million people in the US are diagnosed with bipolar disorders or schizophrenia, with up to a quarter experiencing agitation around 10 to 17 times a year.
BTAI: NASDAQ is up +24.65%
