Merck's Emend approved by FDA to prevent nausea, vomiting after chemotherapy

By Lisa Kerner

Erie, Pa., Jan. 11 - Merck & Co., Inc. said the U.S. Food and Drug Administration has approved Emend (aprepitant) for use with other antiemetic medicines for the prevention of nausea and vomiting associated with chemotherapy.

The FDA approval was based on the findings of a study published in April 2005 in the Journal of Clinical Oncology, according to a company news release.

This multicenter, randomized, double-blind, parallel-group study enrolled 866 breast cancer patients (99.5% women) who had never before undergone emetogenic chemotherapy.

A regimen including Emend in combination with ondansetron and dexamethasone on day 1 followed by Emend on day 2 and 3 was compared to a standard regimen of ondansetron and dexamethasone on day 1 followed by ondansetron on day 2 and 3.

Results showed that a significantly higher proportion of patients treated with the regimen including Emend in cycle 1 reported a complete response, defined as no vomiting and no use of other therapies for nausea or vomiting in the five days after starting chemotherapy.

The study also showed that 64% of patients receiving Emend reported minimal or no impact of nausea and vomiting on their daily life, compared to 56% of patients not receiving Emend.

In cycle 1, clinical adverse experiences were reported in approximately 73% of patients treated with the regimen including Emend compared with approximately 75% of patients treated with the standard regimen. Adverse events included hair loss, fatigue, headache, neutropenia, dyspepsia, stomatitis, pharyngolaryngeal pain and hot flush.

Emend is used to help prevent nausea and vomiting caused by chemotherapy, not to stop nausea and vomiting after they start, said the company.

"Patients with cancer are not only facing a serious illness, they also face the possibility of distressing side effects such as nausea and vomiting from their chemotherapy, and breast cancer patients are particularly susceptible to these side effects," Kelly Pendergrass, M.D., clinical investigator and medical oncologist at the Kansas City Cancer Center said in a company news release.

"The good news is that, with this expanded indication, Emend can now be used with other antiemetics in the wider population of patients receiving moderately emetogenic chemotherapy to help prevent these worrisome and challenging side effects before they occur."

Merck & Co., Inc. discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company is based in Whitehouse Station, N.J.

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