FDA OKs Merck & Co's Emend in combination

US drug major Merck & Co says that the Food and Drug Administration has approved Emend (aprepitant) for use with other antiemetic medicines for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, which are likely to cause nausea and vomiting. Emend, in combination with other antiemetics, is also cleared for the prevention of nausea and vomiting caused by initial and repeat courses of highly-emetogenic chemotherapy treatments, which are very likely to cause nausea and vomiting, including high-dose cisplatin.

The FDA approval for Emend is based on the findings of a study published in April 2005 in the Journal of Clinical Oncology that enrolled 866 breast cancer patients, of whom 99.5% were women. The study compared a regimen including Emend (EMEND in combination with ondansetron, a 5-HT3 receptor antagonist, and dexamethasone, a corticosteroid, on day one followed by Emend on days two and three) and a standard regimen (ondansetron and dexamethasone on day one followed by ondansetron on day two and three).