BTAI - BioXcel Therapeutics' Approved Drug For Bipolar Disorders/Schizophrenia Shows No Evidence Of Worsening Or Withdrawal In Post-Marketing Study | Benzinga
Tuesday, BioXcel Therapeutics Inc (NASDAQ:BTAI) released topline results from a post-marketing requirement (PMR) study of Igalmi (dexmedetomidine) sublingual film that demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose after seven days of PRN (as-needed) treatment.
In the single-arm, open-label study, 28 inpatient adults with frequent episodes of agitation associated with bipolar disorders or schizophrenia self-administered 180 mcg dose of Igalmi as needed over seven days. A total of 83 episodes were treated.
Although the study was not statistically powered ...