FDA staff sug­gests safe­ty pro­file of Sage post­par­tum de­pres­sion drug dis­qual­i­fies it from at-home in­fu­sions

Ahead of Fri­day’s ad­vi­so­ry com­mit­tee pan­el on Sage Ther­a­peu­tics’ $SAGE brex­anolone, FDA re­view­ers rec­om­mend­ed that the post­par­tum de­pres­sion drug be ad­min­is­tered in the pres­ence of a health­care pro­fes­sion­al out­side the pa­tient’s home.

The agency’s main con­cern with the drug for­mer­ly known as SAGE-547 was with an ob­served loss of con­scious­ness  dur­ing in­fu­sion, which oc­curred in 6 of 140 women ex­posed to brex­anolone. Af­ter eval­u­at­ing the dose, blood lev­el, con­cur­rent med­ica­tions, avail­able med­ical his­to­ry, and pa­tient char­ac­ter­is­tics, FDA re­view­ers found no re­la­tion­ship be­tween these fac­tors and the oc­cur­rence of LOC, mak­ing the event un­pre­dictable.

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