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MonoSol Rx Completes Thin Film Ondansetron Pilot Bioequivalence Study
Date:2/21/2008

WARREN, N.J., Feb. 21 /PRNewswire/ -- MonoSol Rx, a drug delivery company specializing in dissolving thin film pharmaceutical products, today announced that it has successfully completed a pilot clinical study for its thin film formulation of ondansetron, a selective 5-HT3 receptor antagonist used in the prevention and treatment of nausea and vomiting.

MonoSol Rx's thin film formulation of ondansetron was studied against GlaxoSmithKline's Zofran ODT(R) product. Based on the results of the study, MonoSol Rx is moving immediately to pivotal trials to enable drug submissions both in the US and Europe. The Company expects to file with the appropriate regulatory authorities in 2008.

A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, "Successful completion of this pilot study marks an important step towards commercializing what we believe is a product with significant benefits over existing formulations of ondansetron. Our thin film formulation of ondansetron is particularly well suited for the target patient population because individuals who are prescribed the drug often have difficulty swallowing due to extreme nausea caused by chemotherapy, radiotherapy and surgical procedures. Incorporating ondansetron into a great-tasting thin film formulation that dissolves quickly in the mouth allows the drug to be easily administered without water, making it more palatable and less likely to cause additional discomfort."

MonoSol Rx's formulation of ondansetron is a new oral formulation expected to be introduced to the market next year. Its indications are the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV), prevention of nausea and vomiting associated with radiotherapy, and prevention of Post-Operative Nausea and Vomiting (PONV).

MonoSol Rx's thin film technology utilizes strategic and proprietary intellectual property that ensures predictable in-vivo performance and provides superior characteristics over
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