Merck & Co's Emend cleared by FDA for nausea in cancer chemotherapy

Merck & Co has been granted approval by the US Food and DrugAdministration for Emend (aprepitant), its new drug for the treatment and prophylaxis of nausea and vomiting in patients undergoing chemotherapy for cancer. The product is indicated for use in combination with other anti-vomiting agents to help prevent the acute and delayed nausea and vomiting associated with initial and repeat courses of highly-emetogenic cancer chemotherapy, including high-dose cisplatin.

The substance P/neurokinin 1 receptor antagonist is the first medicine to be indicated for the prevention of delayed symptoms in this setting, according to Merck. It is also the first drug in this therapeutic class to reach the market; at present, nausea and vomiting treatments work either by targeting serotonin receptors (eg GlaxoSmithKline's ondansetron) or are corticosteroids.

The recommended dosing regimen is a 125mg capsule taken orally one hour prior to chemotherapy (day one), followed by 80mg once-daily in the morning on days two and three. It can be taken with or without food, but is not indicated for chronic management of nausea and vomiting, notes Merck.