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Par Pharma nausea drug approved

Strativa Pharmaceuticals, a division of Par Pharmaceutical Companies, has received US approval for its nausea-prevention drug Zuplenz

Strativa Pharmaceuticals, a division of Par Pharmaceutical Companies, has received US Food and Drug Administration (FDA) approval for its nausea-prevention drug Zuplenz (ondansetron). The drug is the first oral soluble film to be approved in the US as a prescription product.

The product is formulated so that it can be taken with or without water, and under fed or fasting conditions. The film, which dissolves on the tongue, is designed for ease of use by patients who have trouble swallowing or whose nausea and vomiting is worsened by drinking water.

Zuplenz is indicated for the prevention of post-operative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. The product is a new formulation of ondansetron, the active ingredient in GlaxoSmithKline's (GSK) Zofran ODT, an orally disintegrating tablet.

The approval was based on clinical bioequivalence data showing that Zuplenz is comparable to Zofran ODT, an orally dissolving tablet that can also be taken without water.

Zuplenz is formulated using MonoSol Rx's PharmFilm technology. Strativa and MonoSol Rx entered into an exclusive licensing agreement in 2008 for Zuplenz oral soluble film. The FDA approval has triggered $6m in milestone payments to MonoSol Rx under that deal.

The product is expected to be available in retail pharmacies in the third quarter of this year.

7th July 2010

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