BioXcel looks to expand label to at-home use for lead psych drug. Initial data are mixed
BioXcel reported Thursday morning that Igalmi, a drug approved to treat agitation in patients with certain psychiatric disorders, had mixed results in the first part of a Phase III study.
The biotech hopes to use the study to expand Igalmi’s label so the drug can be used at home — and would not have to be administered with a healthcare provider present.
At two hours post-treatment, people who received the drug did not perform significantly differently on a scale that measures agitation from those who received placebo — but the p-value just barely missed the cut at 0.077. But at four hours post-treatment, there was more separation between the two groups, and with a p-value of 0.049, the difference was statistically significant.
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