Strativa Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Zuplenz (ondansetron) 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 US FDA as a prescription medication.
The US FDA approval was granted based on clinical study data comparing the bioequivalence of Zuplenz 8 mg to Zofran ODT (orally dissolving tablet) 8 mg. The pharmacokinetic results of these studies demonstrated that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT.
"The US 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," said John A MacPhee, president, Strativa Pharmaceuticals. "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. Zuplenz will be offered in 4 mg and 8 mg dosage strengths, and is expected to be available in retail pharmacies in the third quarter of 2010.
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.
In June 2008, Strativa and MonoSol Rx entered into an exclusive licensing agreement under which Strativa acquired the US commercialization rights to Zuplenz oral soluble film. Under the terms of the amended agreement, the US FDA approval triggered Strativa's payments to MonoSol Rx of a US$ 4.0 million approval milestone and a US$ 2.0 million pre-launch milestone.
Strativa Pharma, the proprietary products division of a wholly-owned subsidiary of Par Pharmaceutical Companies, Inc, excels at finding, enhancing, and bringing to market drugs that make a meaningful difference to patients.
Par Pharmaceutical Companies, Inc is a US-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm technology to deliver drugs in lingual, sub-lingual and buccal dissolving films.