MonoSol Rx Announces FDA Approval Of Zuplenz(R) Oral Soluble Film For Treatment Of Nausea And Vomiting

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 09 Jul 2010 - 1:00 PDT

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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, 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 in2 and 1.09 in2 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."

Keith Kendall, Executive Vice President and CFO of MonoSol Rx said, "Zuplenz has the potential to create significant value as a differentiated anti-emetic therapy that is formulated in a convenient, easy-to-administer oral soluble film. Importantly, we have enjoyed a successful working relationship with Strativa, reflected in the FDA's approval of Zuplenz and the recent extension of our partnership. We look forward to continuing this valuable relationship and creating opportunities for additional collaborations."

Paolo Galfetti, CEO of APR stated, "APR, Labtec and MonoSol Rx truly understand the value that film drug delivery offers throughout the pharmaceutical industry. Given our shared expertise, this collaboration creates a unique opportunity to broaden the development reach for prescription film products. We look forward to leveraging the capabilities and skills of our partners Monosol Rx and Labtec as well as the unique attributes of this film technology to advance several drug targets for film delivery."

MonoSol Rx, APR and APR's European partner, Labtec, are collaborating to promote the global development of oral films containing ondansetron as well as other drug candidates. In June 2010, MonoSol Rx announced an expansion of its joint collaboration agreement with APR to identify and develop film formulations of prescription drug products beyond ondansetron and donepezil to include Zolmitriptan. Zolmitriptan is currently commercially available for the treatment of migraine headaches in adults, and faces initial patent expirations in 2013.

Indication and Important Safety Information

Zuplenz is indicated for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

The concomitant use of apomorphine with ondansetron is contraindicated based upon reports of profound hypotension and loss of consciousness.

Zuplenz is contraindicated for patients known to have hypersensitivity to the drug.

The most common adverse drug reactions (≥5%) reported in clinical trials of patients receiving ondansetron for prevention of nausea and vomiting associated with cancer chemotherapy or concurrent radiotherapy were headache, malaise/fatigue, constipation, diarrhea, and dizziness. In addition, the most common adverse event reported for postoperative nausea and vomiting and occurring at a rate significantly different from placebo was headache.

Source:
MonoSol Rx
APR Applied Pharma Research s.a.
Strativa Pharmaceuticals

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