Updated labeling for Merck's anti-emetic Emend (aprepitant) highlights the drug's superiority over GlaxoSmithKline's Zofran (ondansetron) for the treatment of post-operative nausea and vomiting. FDA approved Emend for the PONV indication June 30.

The drug has been approved for the prevention of chemotherapy-induced nausea and vomiting in combination with other anti-emetics since 2003. Emend is an NK-1 receptor agonist that is believed to block nausea and vomiting signals to the brain, Merck said, pointing out that the drug is the first new class of therapy for the management of PONV in more than 10 years.

Zofran, a 5-HT3 receptor agonist, is approved for PONV, chemotherapy-induced nausea and vomiting and for radiation-induced nausea and vomiting.

Labeling for Emend notes that in the first of two clinical trials supporting the approval, "the use of aprepitant did not affect the time to first use of rescue medication when compared to ondansetron. However, compared to the ondansetron group, use of aprepitant delayed the time to first vomiting."

In the trial, 84% of Emend patients had no emetic episodes 24 hours following surgery, compared to 71% of patients treated with Zofran.

In the second study, the trial failed to meet its primary endpoint of Emend superiority over Zofran in the prevention of PONV as measured by the proportion of patients with complete response in 24 hours following surgery, labeling says.

However, "The study demonstrated that both dose levels of aprepitant had a clinically meaningful effect with respect to the secondary endpoint 'no vomiting' during the first 24 hours after surgery and showed that the use of 40 mg aprepitant was associated with a 16% improvement over ondansetron for the no vomiting endpoint."

The two double-blind trials enrolled 1,658 patients who were randomized to receive Emend orally or Zofran intravenously.

Administration of Emend for PONV is recommended at a dose of 40 mg within three hours prior to induction of anesthesia.

- Jonathan Block

Merck Anti-Emetic Emend Adds Postoperative Nausea Indication

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