Merck announced results from a Phase 3 study to evaluate the safety and efficacy of Emend (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.
The Phase 3 double-blind, active-comparator study, randomized 302 patients who were receiving emetogenic chemotherapy to receive an Emend plus ondansetron regimen (n=152) or a control regimen (placebo plus ondansetron) (n=150). The primary endpoint of the study was complete response (no vomiting, no retching, and no use of rescue medication for nausea and vomiting) in the delayed phase (25–120 hours following initiation of chemotherapy).
The use of the Emend regimen for CINV prevention was significantly more effective than a control regimen in achieving complete response. In the study, 51% of patients receiving the Emend regimen achieved the primary endpoint of complete response in the delayed phase of CINV, vs. 26% of those in the control group (P<0.0001).
Emend, a Substance P/Neurokinin-1 (NK1) receptor antagonist is already approved for use in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
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