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FDA Approves Aloxi(R) (Palonosetron HCL) Injection for Prevention of Postoperative Nausea and Vomiting
Date:3/2/2008

WOODCLIFF LAKE, N.J., March 2 /PRNewswire/ -- Eisai Corporation of North America, its U.S. subsidiary, MGI PHARMA, INC., and Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved Aloxi(R) (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.

Aloxi, available in the United States since 2003, is the first and only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist approved by the FDA for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

The new indication is based on one double-blind Phase III study that evaluated the efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. In the trial, 574 patients undergoing elective gynecologic or abdominal laparoscopic surgery (predominately in the out-patient setting) were randomized to receive one of three single intravenous doses of Aloxi (0.025 mg, 0.050 mg or 0.075 mg) or placebo prior to administration of anesthesia. The effectiveness of Aloxi in PONV was assessed on the day of surgery (0-24 hours) and for two subsequent days (24-72 hours).

The trial successfully met its co-primary endpoint of Complete Response (CR) - defined as no emesis (vomiting) or use of rescue medication - for the 0-24-hour time period (42.8% of patients treated with the approved dose of Aloxi 0.075 mg experienced a CR, compared to 25.9% of patients given placebo [p=0.0035]). For the co-primary endpoint of CR for the 24-72-hour postoperative period, 48.6% of patients treated with Aloxi 0.075 mg experienced a CR, compared to 40.7% of patients given placebo (p=0.1877, not significant).

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SOURCE Eisai Corporation of North America
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