FDA's approach to weighing "non-positive" efficacy data against results from two successful clinical trials for Fabre-Kramer Pharmaceuticals Inc.'s antidepressant Travivo (gepirone extended-release) drew protests from some members of the Psychopharmacologic Drugs Advisory Committee Dec. 1.
Agency reviewers conducted a post hoc analysis of four unsuccessful, active-controlled, gepirone trials using an endpoint that was not the studies' primary outcome