If Sponsors Don’t Ask, FDA Can’t Always Deliver: Merck’s Suvorexant Dosing Debacle
Sponsors may need to be more proactive in reaching out to the agency if they want to avoid the kind of dosing confusion currently facing Merck’s insomnia drug suvorexant, FDA indicates.
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Merck’s “complete response” for insomnia drug suvorexant indicates FDA wants drug doses the company has said are ineffective.
Structured Risk-Benefit Framework Strikes Back: FDA Suvorexant Reviewer Cites Need for Real World Predictions
A predictable risk-benefit framework for FDA drug approval decisions has been a long-term objective of many drug developers. A big step in that direction was adopted as part of the PDUFA V agreement last July. However, FDA's briefing documents for a review of a Merck insomnia therapy suggest that step may not be heading in quite the way that industry hoped.
Merck favors the subjective study endpoints, perhaps with an eye toward potential marketing challenges, and the Rozerem experience could haunt Merck’s dreams.