On Track to File NDA with FDA in Early to Mid-2009
WOODCLIFF LAKE, N.J., Dec. 2 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its development partner, MonoSol Rx, reported the successful completion of all pivotal bioequivalence studies for a thin film formulation of ondansetron. The ondansetron thin film product is being developed for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.
Subject to final review of the data and discussions with the Food and Drug Administration (FDA), it is anticipated that Strativa and MonoSol Rx could file a New Drug Application (NDA) in early to mid 2009.
In June 2008, MonoSol Rx and Strativa entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx. Under terms of the agreement, MonoSol Rx will receive milestone payments prior to commercial launch and sales-based milestones that could total $23.5 million as well as payments for the purchase of product supply and royalties on net sales. The successful achievement of all pivotal bioequivalence studies triggered a milestone payment to MonoSol Rx.
John A. MacPhee, president of Strativa, said, "Completion of the pivotal bioequivalence trials is a significant milestone in the development and commercialization process for our thin film ondansetron formulation. Working with MonoSol Rx we were able to demonstrate that the thin film formulation is bioequivalent to the FDA approved Zofran ODT(R) product in all human clinical trials."
Anti-emetic therapies constit
|SOURCE Par Pharmaceutical Companies, Inc.|
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