WOODCLIFF LAKE, N.J.—In early JulyStrativa Pharmaceuticals announced U.S. Food and Drug Administration(FDA) approval of Zuplenz (ondansetron), an oral-soluble film for theprevention of postoperative, highly and moderately emetogenic cancerchemotherapy-induced, and radiotherapy-induced nausea and vomiting.Notably, this unique formulation of ondansetron, is reportedly thefirst oral-soluble film approved by the FDA as a prescriptionmedication.
The FDA approval was granted based onclinical study data comparing the bioequivalence of Zuplenz 8 mg toZofran ODT (orally dissolving tablet) 8 mg. According to Strativa,the pharmacokinetic results of these studies demonstrated that asingle dose of Zuplenz, taken with or without water and under fed andfasting conditions, was comparable to Zofran ODT.
"The FDA approval of Zuplenz marks animportant milestone for Strativa as it reinforces our commitment toenhancing prescription products to meet the different needs ofpatients," says John A. MacPhee, president of Strativa. "Zuplenzoffers an innovative and convenient, easy-to-take formulation forpatients who have trouble swallowing tablets, while providing thetrusted efficacy expected from ondansetron."
Zuplenz uses proprietary PharmFilm oralsoluble film technology from MonoSol Rx to rapidly dissolve on thetongue without the need for water, which can cause additionaldiscomfort for some patients suffering from nausea and vomiting.Zuplenz will be offered in 4 mg and 8 mg dosage strengths, and isexpected to be available in retail pharmacies in the third quarter of2010.
Nausea and vomiting is a common sideeffect associated with chemotherapy, radiotherapy, and surgery. Leftuntreated, nausea and vomiting can have serious consequences such asexhaustion, dehydration and undernourishment, which can interferewith treatment and healing.
In June 2008, Strativa and MonoSol Rxentered into an exclusive licensing agreement under which Strativaacquired the U.S. commercialization rights to Zuplenz oral solublefilm. Under the terms of the amended agreement, the FDA approvaltriggered Strativa's payments to MonoSol Rx of a $4 millionapproval milestone and a $2 million pre-launch milestone.