FDA Approves Zuplenz Oral Soluble Film

The US Food and Drug Administration (FDA) has approved an oral soluble form of Zuplenz, a drug to prevent nausea and vomiting induced by chemotherapy or radiotherapy. Zuplenz, a formulation of ondansetron, uses oral soluble film technology to rapidly dissolve on the tongue without the ne

The US Food and Drug Administration (FDA) has approved an oral soluble form of Zuplenz, a drug to prevent nausea and vomiting induced by chemotherapy or radiotherapy.

Zuplenz, a formulation of ondansetron, uses oral soluble film technology to rapidly dissolve on the tongue without the need for water.

Strativa Pharmaceuticals president John MacPhee said Zuplenz offers a convenient, easy-to-take formulation for patients who have trouble swallowing tablets.

Results from a study measuring the bioequivalence of Zuplenz to an orally dissolving tablet of Zofran found that the two drugs were comparable.

Strativa acquired the US commercialisation rights to Zuplenz oral soluble film in 2008, as part of an exclusive licensing agreement with MonoSol RX.