Emend aprepitant: Phase III data
A double-blind, international Phase III trial in 302 cancer patients ages 6 months-17 years receiving moderately, highly or very highly emetogenic chemotherapy showed that Emend plus ondansetron met the primary endpoint of improving complete response rate, defined as no vomiting, no retching and no use of rescue medication for nausea and vomiting, in the delayed phase of CINV from 25-120 hours following initiation of chemotherapy vs. placebo plus ondansetron (51% vs. 26%, p<0.0001). Emend plus ondansetron also met the secondary endpoints of improving complete response rates in the acute (66% vs. 52%, p=0.0135) and overall (40% vs. 20%, p=0.0002) phases of CINV vs. placebo plus ondansetron. Additionally, Emend plus ondansetron met the secondary endpoint of a greater proportion of patients with no vomiting in the overall phase vs. placebo plus ondansetron (47% vs. 21%, p<0.0001). Emend was delivered as capsules or as a powder for suspension formulation based on weight. Data were presented at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology meeting in Miami. ...