BioXcel Therapeutics Inc. shares were up 11% to $22 after the company said 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 biopharmaceutical company said Igalmi can be self-administrated by patients under the supervision of a healthcare provider.
BioXcel said it is prepared to launch Igalmi in the U.S. in the second quarter of 2022.
The FDA approval of Igalmi is based on data from two placebo-controlled, parallel group Phase 3 trials evaluating Igalmi for the acute treatment of agitation associated with schizophrenia, or bipolar I or II disorder.
The primary endpoint was the mean change from baseline in the Positive and Negative Syndrome Scale-Excited Component total score assessed at two hours following dosing. The key secondary endpoint was the earliest time where efficacy, measured by the change from baseline in score, was statistically separated from placebo.
In both trials, Igalmi said that it 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, the company said.
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