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news.MGI Pharma and its partner Helsinn Healthcare have reported the successful completion of two phase III trials of Aloxi injection for the prevention of post-operative nausea and vomiting.
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Two phase III clinical trials were conducted to evaluate the safety and efficacy of Aloxi compared to placebo for the prevention of post-operative nausea and vomiting following elective outpatient abdominal or gynecological laparoscopic surgery or elective inpatient gynecological or breast surgery.
Both clinical trials successfully met the primary efficacy endpoint of complete response for the 0-24 hour time period following surgery for the selected dose of 0.075mg. In addition, both trials achieved the secondary endpoints of complete response for the 0-48 and 0-72 hour time periods.
Based on these results, Helsinn and MGI Pharma plan for the submission of a supplemental new drug application to the FDA during the first half of 2007.
Aloxi is already approved by the FDA for the prevention of nausea and vomiting associated with cancer chemotherapy.
“We and our partner Helsinn are pleased with the results of these phase III trials of Aloxi and believe that they describe a product profile with an extended period of activity,” said Lonnie Moulder, president and CEO of MGI Pharma.