MERCK RECEIVES FDA APPROVAL FOR EMEND

The FDA has approved Merck's Emend, the first new class of postoperative nausea therapy in 10 years, the company said in a July 11 release.

The agency approved Emend (aprepitant) to prevent postoperative nausea and vomiting, one of the most common side effects of surgery. Emend blocks nausea and vomiting signals to the brain, which is distinct from current anti-vomiting therapies, Merck said. Current treatments, known as 5-HT3 receptor antagonists, target nausea and vomiting signals in the gut.

The FDA approval was based on two studies of 1,658 patients undergoing open abdominal surgery. These studies found that Emend was superior to Zofran, a 5-HT3 receptor antagonist, Merck said. For example, in the first study 84 percent of patients taking Emend did not experience vomiting through 24 hours after surgery as opposed to 71 percent of the patients taking Zofran (ondansetron hydrochloride).

The agency previously approved Emend for chemotherapy patients in 2003.