Phase 3 study of Emend for Injection regimen met primary endpoint
Posted: 29 June 2015 |
Merck has announced results from a Phase 3 study investigating single-dose Emend for Injection for the prevention of CINV associated with MEC…
Merck has announced results from a Phase 3 study investigating the safety and efficacy of single-dose Emend (fosaprepitant dimeglumine) for Injection in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic (vomit-inducing) chemotherapy (MEC).
In the study, the first to evaluate an intravenous NK-1 receptor antagonist for the prevention of CINV associated with MEC, the single-dose Emend for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines.
“The results from this important Phase 3 trial are very encouraging as they are the first study to evaluate Emend for Injection in a combination regimen for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy – and show the potential to use a single day antiemetic regimen,” said Dr Bernardo L. Rapoport, principal investigator for the study and chief medical oncologist, Medical Oncology Centre of Rosebank, Johannesburg, South Africa.
Merck plans to submit new data for Emend for Injection to the FDA later this year
“Nausea and vomiting remain a significant burden for patients receiving chemotherapy and we look forward to submitting these data for Emend for Injection to the US Food and Drug Administration,” said Stuart Green, vice president, clinical research, Merck Research Laboratories. “This study builds on our decade of research for Emend and Merck’s overall commitment to help people with cancer.”
Emend for Injection is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer (HEC) chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of MEC. Emend has not been studied for treatment of established nausea and vomiting.
Merck plans to submit the recent data to the US Food and Drug Administration in the second half of 2015 to seek approval for a regimen containing single-dose Emend for Injection for the prevention of CINV associated with MEC.