MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, in collaboration with APR Applied Pharma Research s.a. of Switzerland ("APR") and Labtec GmbH of Germany, today announced that its partner, Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), has received approval from the U.S. Food and Drug Administration (FDA) for Zuplenz® (ondansetron) oral soluble film ("OSF") for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz is the first oral soluble film product approved by the FDA as a prescription medication.
Zuplenz is a unique formulation of ondansetron developed using MonoSol Rx's proprietary PharmFilm® technology, and co-developed with partner APR. It is based on a novel and proprietary oral drug delivery technology platform and consists of a polymeric OSF containing ondansetron. The OSF is 0.55 in and 1.09 in for the 4mg and 8 mg dosage, respectively. Once placed in the mouth, it dissolves in a few seconds and is swallowed with the saliva without the need for water.
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. 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.
In June 2008, Strativa and MonoSol Rx entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to the ondansetron oral soluble film. Under the terms of the agreement, the FDA approval triggered Strativa's payments to MonoSol Rx of a $4.0 million approval milestone and a $2.0 million pre-launch milestone. In January 2010, the companies announced that they entered into a new licensing and development agreement that grants the option to develop three new products.
A. Mark Schobel, President and CEO of MonoSol Rx, stated, "We are thrilled to announce the first FDA approval of a prescription product that utilizes our proprietary PharmFilm® Technology. This approval validates both the utility of Zuplenz as an anti-emetic therapy, as well as the agency's acceptance of PharmFilm® as a viable prescription dosage form. We look forward to partnering with Strativa and other leading pharmaceutical companies in the development and commercialization of additional prescription drug products that target patient populations and therapeutic categories where film has the potential to provide dosing advantages, revenue life cycle extensions and competitive differentiation."