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FDA Approves ALOXI(R) (Palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting
Date:8/23/2008

WOODCLIFF LAKE, N.J., Aug. 23 /PRNewswire/ -- Eisai Corporation of North America and its partner Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved a new oral formulation of ALOXI(R) (palonosetron hydrochloride) for the prevention of chemotherapy-induced nausea and vomiting (CINV). ALOXI Capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5 mg ALOXI Capsule is administered approximately one hour prior to the start of chemotherapy.

ALOXI (palonosetron hydrochloride) injection 0.25 mg, a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, has been available in the United States for intravenous administration since 2003 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. A single 0.25 mg intravenous dose of ALOXI is administered approximately 30 minutes before the start of chemotherapy.

About Chemotherapy-Induced Nausea and Vomiting (CINV)

Research has shown that patients with cancer consider CINV among the most dreaded side effects following therapy. Despite prophylactic antiemetics, on the day of chemotherapy, about 30-45 percent of patients experience nausea or vomiting or require rescue therapy following administration of moderately emetogenic chemotherapy. Failure to control acute nausea and vomiting on the first day of chemotherapy will increase the risk of nausea and vomiting on subsequent days and in subsequent cycles of chemotherapy.

About ALOXI Capsules for Oral Administration

ALOXI (palonosetron HCl) Capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting associated with initi
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SOURCE Eisai Corporation of North America
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