WOODCLIFF LAKE, N.J. — Later this year, Strativa Pharmaceuticals plans to ship Zuplenz oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced and radiotherapy-induced nausea and vomiting.
Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the Food and Drug Administration as a prescription medication, according to Strativa. Plans call for Zuplenz to be offered in 4 mg and 8 mg dosage strengths and to be available at retail pharmacies in the third quarter.
The FDA approval was granted based on clinical study data comparing the bioequivalence of Zuplenz 8 mg to Zofran ODT (orally dissolving tablet) 8 mg, Strativa said. The pharmacokinetic results of the studies showed that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT.
"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," commented John MacPhee, president of Strativa. "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."
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.
Nausea and vomiting is a common side effect associated with chemotherapy, radiotherapy and surgery. Left untreated, nausea and vomiting can have serious consequences, such as exhaustion, dehydration and undernourishment, which can interfere with treatment and healing, Strativa noted.
In June 2008, Strativa and MonoSol Rx entered into an exclusive licensing agreement in which Strativa acquired the U.S. commercialization rights to Zuplenz oral soluble film. Under the terms of the amended agreement, the FDA approval triggered Strativa’s payments to MonoSol Rx of a $4 million approval milestone and a $2 million prelaunch milestone.
Strativa is the proprietary products division of Par Pharmaceutical Cos.
