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Oral formulation of Aloxi approved in the US

This article was originally published in Scrip

Executive Summary

A new oral capsule formulation of Helsinn Healthcare/Eisai's 5HT3-antagonist Aloxi (palonosetron hydrochloride) has been approved by the US FDA for the prevention of nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5mg capsule is administered around one hour before treatment. A 0.25mg iv formulation of the product has been available in the US since 2003 for the prevention of acute and delayed nausea and vomiting in the same setting and also for prevention of acute nausea and vomiting from initial and repeat courses of highly emetogenic chemotherapy. Eisai acquired North American rights as part of its January purchase of MGI Pharma, which had licensed these from Helsinn. A 0.075mg iv formulation was launched in the US in July for the prevention of postoperative nausea and vomiting for up to 24 hours following surgery.

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