MGI Pharma and Helsinn say Aloxi met pivotal study endpoint

The multi-center Phase III trial compared Aloxi (palonosetron hydrochloride) injection to placebo for the prevention of post-operative nausea and vomiting (PONV) following elective inpatient gynecologic or breast surgery.

The study was designed to assess the incidence, time course, and treatment patterns associated with PONV and post-discharge nausea and vomiting (PDNV) over three days. Female patients undergoing elective inpatient gynecological or breast surgery were stratified for history of PONV and motion sickness and were randomly assigned to receive one of three single intravenous doses of Aloxi or placebo prior to receiving anesthesia.

The results show that the study successfully met its primary efficacy endpoint, with complete response rates for the selected dose of Aloxi 0.075mg significantly higher than those for placebo during the 0-24 (56% versus 36%) and 24-72 (70% versus 52%) hour time periods following surgery.

Occurrences of nausea, as measured by a four-point categorical scale (‘none’ to ‘severe’), were less intense in patients who received Aloxi 0.075mg compared with patients who received placebo in the 0-6 hour, 6-72 hour, and 0-72 hour intervals. The incidence, pattern, and intensity of adverse events were similar among all treatment groups including placebo, and the most frequently observed side effects were headache and constipation.