MonoSol Rx Announces FDA Acceptance Of NDA For Ondansetron Orally Dissolving Film Strip

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 11 Jun 2009 - 5:00 PDT

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MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, announced that the new drug application (NDA) for ondansetron orally dissolving film strip (ODFS) has been accepted for review by the U.S. Food and Drug Administration (FDA). Ondansetron ODFS was developed using MonoSol Rx's proprietary PharmFilm(R) technology to deliver the anti-emetic therapy ondansetron in a thin film strip that rapidly dissolves on the tongue.

MonoSol Rx and its partner Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), are seeking FDA approval of ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery. The NDA is supported by positive data from successfully completed pivotal bioequivalence studies against ondansetron ODT (orally disintegrating tablets), both with and without water. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to respond to the NDA by the first quarter of 2010.

A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, "The FDA's acceptance of the NDA for our ondansetron orally dissolving film strip further validates the acceptance of thin film as a new prescription dosage form. With our licensing partner Strativa we are one step closer to providing a promising new formulation of an anti-emetic therapy that leverages our PharmFilm(R) drug delivery technology. By delivering the drug orally through a rapidly dissolving film strip that requires no water, ondansetron ODFS has advantages over tablets or liquid medications, which can exacerbate nausea in these patients."

The anti-emetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescription leader in the category, accounting for 95% of prescriptions.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm(R) technology to deliver drugs in quick dissolving films. PharmFilm(R) is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in thin film drug delivery is supported by strong intellectual property, a portfolio of commercialized over-the-counter (OTC) drug products, and a development pipeline of prescription formulations based on PharmFilm(R) technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that fund prescription product development programs that will generate long-term value.

The Company's commercialization strategy for all PharmFilm(R) products is to partner with the innovator, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For existing and future partners, PharmFilm(R) formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm(R) is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).

About Strativa Pharmaceuticals

Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for commercialization and to help ensure their success after launch.

About Par Pharmaceutical

Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.

Source: MonoSol Rx