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news.Strativa Pharmaceuticals has received FDA approval for Zuplenz (ondansetron) oral soluble film, for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.
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Zuplenz, a formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.
Strativa Pharma said that the FDA approval was based on the study comparing the bioequivalence of Zuplenz 8mg to Zofran ODT (orally dissolving tablet) 8mg.
The pharmacokinetic (PK) study results showed that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT.
Zuplenz uses proprietary PharmFilm oral soluble film technology from MonoSol Rx to rapidly dissolve on the tongue without the need for water, which can cause additional discomfort for some patients suffering from nausea and vomiting.
Strativa Pharma will make available Zuplenz in retail pharmacies in the third quarter of 2010 in two dosage strengths 4mg and 8mg.
Earlier, Strativa acquired the US commercialisation rights of Zuplenz oral soluble film under a contract signed between Strativa and MonoSol Rx in June 2008.
As per the terms of the amended agreement, the FDA approval triggered Strativa Pharma ‘s payments to MonoSol Rx of $4m approval milestone and a $2m pre-launch milestone.
John MacPhee, president of Strativa Pharma, said: “The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment to enhancing prescription products to meet the different needs of patients.
“Zuplenz offers an innovative and convenient, easy-to-take formulation for patients who have trouble swallowing tablets, while providing the trusted efficacy expected from ondansetron.”