Merck announced results from a Phase 3 study of single-dose Emend (fosaprepitant dimeglumine) for injection in combination with other anti-vomiting medications for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic chemotherapy (MEC).
In the global randomized, double-blind study, more than 1,000 patients receiving MEC were randomly assigned to receive either 150mg single-dose Emend for Injection in combination with 16mg ondansetron capsules and 12mg dexamethasone capsules (n=504) on day one, followed by oral placebo for ondansetron on days two and three; or an active control regimen consisting of placebo (saline IV) in combination with 16mg ondansetron and 20mg dexamethasone (n=497) on day one, followed by 8mg ondansetron on days two and three. The primary endpoint of the study was complete response (CR) (as measured by no vomiting and no use of rescue medication for nausea or vomiting) in the delayed phase (25–120 hours following initiation of chemotherapy).
For the primary study endpoint, the Emend for Injection regimen provided higher incidence of CR in Days 2–5, with CR observed in 78.9% of patients receiving the Emend for Injection regimen vs. 68.5% in the active control group (P<0.001).
Emend is already indicated in combination with other antiemetic agents to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of moderately to highly emetogenic cancer chemotherapy, including high-dose cisplatin. It is also approved for the prevention of post-op nausea and vomiting.
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