Merck has reported results from a global, investigational Phase III trial of Emend (aprepitant) for prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged six months to 17 years.
The Phase III trial is designed to assess the safety and efficacy of Emend in these patients.
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In this trial, use of the Emend regimen for CINV prevention was significantly more effective than a 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.
Merck Research Laboratories clinical research vice-president Stuart Green said: "In this large pediatric study, adding Emend to a standard regimen for prevention of CINV resulted in significant reduction of emetic events."
Based on the results, the company plans worldwide regulatory submissions for Emend, starting in the US, for use in preventing CINV in pediatric and adolescent cancer patients.
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In the US, the company intends to file a new drug application (NDA) for a new pediatric formulation (powder for suspension) and a supplemental NDA for use of the current formulation (capsules).
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By GlobalDataAccording to the company, both NDA and sNDA submission are planned for the second half of 2014.
Emend is a Substance P/Neurokinin-1 (NK1) receptor antagonist approved for use in combination with other antiemetic agents.
The drug is indicated in adults 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 as well as for prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
A total of 302 patients were enrolled in the randomised, double-blind, active-comparator Phase III trial, which evaluated Emend for prevention of CINV in children.
In the trial, patients receiving emetogenic chemotherapy were randomly assigned to receive an Emend plus ondansetron regimen or a control regimen (placebo plus ondansetron).
