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Published on 7/11/2006 in the Prospect News Biotech Daily.

Merck's anti-nausea therapy Emend gets FDA approval

By Elaine Rigoli

Tampa, Fla., July 11 - Merck & Co., Inc. said it received Food and Drug Administration approval of Emend (aprepitant) for the prevention of postoperative nausea and vomiting, which the company said is one of the most common side effects associated with surgical procedures.

The recommended dose of Emend for the post-op setting is a single, oral 40 mg dose administered within three hours prior to the induction of anesthesia.

The FDA approval for Emend is based on two multi-center, randomized, double-blind, active comparator-controlled, parallel-group studies of 1,658 patients undergoing open abdominal surgery.

Emend belongs to a class of medications called substance P/neurokinin 1 receptor antagonists and is believed to work through a novel mechanism, which primarily blocks nausea and vomiting signals to the brain.

The company said this is distinct from how current anti-vomiting therapies work, including 5-HT3 receptor antagonists (Zofran), which primarily target nausea and vomiting signals in the gut.

Merck is a research-driven pharmaceutical company with headquarters in Whitehouse Station, N.J.


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