MonoSol Rx and Strativa file NDA for ondansetron orally dissolving film strip

Fri. April 10, 2009; Posted: 01:11 PM

Apr 10, 2009 (Datamonitor via COMTEX) -- MSRX | Quote | Chart | News | PowerRating -- MonoSol Rx, a specialty pharmaceutical company, and Strativa Pharmaceuticals, the products division of Par Pharmaceutical Companies, have submitted a new drug application to the FDA for the orally dissolving film strip formulation of ondansetron.

The new drug application (NDA) is supported by positive data from completed pivotal studies in which ondansetron orally dissolving film strip (ODFS) demonstrated bioequivalence against GlaxoSmithKline's Zofran ODT anti-emetic product.

The ondansetron ODFS product has been developed as an anti-emetic therapy for the prevention of chemotherapy-induced nausea and vomiting, nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.

MonoSol Rx and Strativa have previously entered into an exclusive licensing agreement under which Strativa acquired the US commercialization rights to the ODFS formulation of ondansetron from MonoSol Rx. Under terms of the agreement, MonoSol Rx will receive pre-commercialization and sales-based milestone payments that could total $23.5 million, as well as payments for the purchase of product supply and royalties on net sales.

Mark Schobel, president and CEO of MonoSol Rx, said: "The submission of the NDA for our ondansetron orally dissolving film strip marks another key milestone for MonoSol Rx and our licensing partner, Strativa Pharmaceuticals. This sets the stage for a promising new therapy to combat nausea resulting from chemotherapy, radiotherapy and surgical procedures."

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