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Merck On Track To File Novel Sleep Aid Suvorexant In 2012

This article was originally published in The Pink Sheet Daily

Executive Summary

Merck announced its potential first-in-class dual orexin receptor antagonist suvorexant successfully completed a second Phase III trial, apparently without safety concerns that led Actelion/GlaxoSmithKline to drop their DORA almorexant a year ago on Phase III results.

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After FDA abruptly cancelled an advisory committee meeting on the anesthesia injection product in July to review trial site inspection results for a hypersensitivity study, it issues a “complete response” letter indicating site “operational” concerns.

Sugammadex Clinical Trial Issues Still Causing Trouble For Merck

After FDA abruptly cancelled an advisory committee meeting on the anesthesia injection product in July to review trial site inspection results for a hypersensitivity study, it issues a “complete response” letter indicating site “operational” concerns.

FDA Needs More Time To Review Sugammadex Inspection Report, Cancels Advisory Committee

Merck’s anesthesia reversal agent, which was deemed “not approvable” in 2008, faces another setback as FDA cancels its July 18 advisory committee meeting to allow more time to review clinical trial site inspection data.

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