Emend: Phase III data
A double-blind, international Phase III trial in 1,001 patients receiving moderately emetogenic chemotherapy showed that a single dose 150 mg Emend for Injection plus ondansetron and dexamethasone met the primary endpoint of a greater proportion of complete responders, defined as no vomiting and no use of rescue medication for nausea or vomiting in the delayed phase (25 to 120 hours after starting chemotherapy), vs. placebo plus ondansetron and dexamethasone (78.9% vs. 68.5%, p<0.001). On secondary endpoints, Emend for Injection plus ondansetron and dexamethasone improved complete response rate in the acute phase (0 to 24 hours after starting chemotherapy) (93.2% vs. 91%, p=0.184) and overall (0 to 120 hours after starting chemotherapy) (77.1% vs. 66.9%, p<0.001) vs. placebo plus ondansetron and dexamethasone. ...