Do Negative Trials Count More Than Successful Ones?
This article was originally published in The Pink Sheet Daily
Fabre-Kramer, FDA dispute over efficacy of the antidepressant gepirone heads to Psychopharmacologic Drugs Advisory Committee.
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Alkermes revealed successful completion of its third Phase III trial for the depression drug ALKS 5461 as well as a risky plan to seek FDA approval based on two negative and one positive late-stage study.
Fabre-Kramer responds to Office of New Drugs Director Jenkins' invitation to submit additional information following advisory committee review; Jenkins' decision on the antidepressant now expected by end of January.
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.