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Sepracor gets FDA input on antidepressant plans

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sepracor is "evaluating the possible initiation" of a Phase III registrational trial for its serotonin/norepinephrine reuptake inhibitor SEP-227162, after hearing from FDA that the agency has agreed with key elements of Sepracor's plans. In 2008, the firm submitted a briefing package to the agency outlining a proposal to conduct an abbreviated Phase III program for the dual reuptake inhibitor. Sepracor has also fully enrolled a Phase II study for its novel triple reuptake inhibitor for depression, SEP-225289, with clinical results anticipated in the third quarter

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