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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