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Merck & Co Inc announces data from investigational phase 3 study on EMEND


Monday, 30 Jun 2014 08:00am EDT 

Merck & Co Inc:Results from global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.In this study in pediatric cancer patients undergoing very highly, highly, or moderately emetogenic (vomit-inducing) chemotherapy.Says use of EMEND regimen for CINV prevention was significantly more effective than control regimen in achieving Complete Response, defined as no vomiting or retching and no use of rescue medication for nausea and vomiting, in all phases of CINV (acute, delayed, and overall).Nausea and vomiting are common complications of cancer chemotherapy and can be particularly distressful and debilitating to pediatric cancer patients.Based on these data, Merck plans worldwide regulatory submissions for EMEND (aprepitant), beginning in the United States, for use in the prevention of CINV in pediatric and adolescent cancer patients (ages 6 months to 17 years).In the United States, Merck plans to submit a New Drug Application (NDA) for a new pediatric formulation (powder for suspension) and a supplemental NDA for use of the current formulation (capsules).Both filings are planned for the second half of 2014. 

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