Defining 'Substantial Efficacy': Post Hoc Analysis OK (When FDA Does It)

Agency's interpretation of four unsuccessful trials of Fabre-Kramer's antidepressant seems like 'cherry picking' and could create an uneven playing field for sponsors, some advisory committee members say; nevertheless, panel overwhelmingly concludes efficacy was lacking.

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

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