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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.

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