FDA Response to ODFS’s NDA Anticipated (NYSE:PRX)

Strativa Pharmaceuticals is a subsidiary owned by the Par Pharmaceutical Companies, Inc. (NYSE:PRX), a specialty pharmaceutical company that is involved in the development, manufacturing and commercialization of both generic drugs and novel branded drugs. Recently, Strative has discovered and developed a drug – known as the ondansestron orally dissolving film strip (ODFS). The company believes that the drug can be successfully used to prevent side effects, such as nausea and vomiting, that are faced by patients who are undergoing severely and mildly emotegonic chemotherapy, surgery and radiotherapy. The company wanted to bring Strative into market. As a result, in order to get the approval from the United States of America’s Food & Drug Administration (FDA), it submitted a New Drug Application to the regulator. On June 10, 2009, the company disclosed to its stockholders that the FDA has found that its submitted NDA was complete enough to allow a thorough review by the FDA – that is, the NDA had been accepted for filing. The FDA had also given Strative a Prescription Drug User Fee Act date – also called Action date or just PDUFA date – of February 7, 2010. This is the date on which the FDA must provide a response to Strative regarding the latter’s submitted NDA.

Strativa developed the ODFS with the help of PharmaFilm™ thin film technology that is owned by MonoSol Rx. The drug is a novel type of ondansetron that can be taken orally and that can dissolve very fast on the tongue. The company has carried out several clinical studies on the drug. In all the studies, the ODFS has shown “bioquivalance” to ordansetron ODT (orally disintegrating tablets) – both in the presence and in the absence of water.

Following the news of the acceptance of the NDA by the FDA, John A. MacPhee, who is the President of Strativa, said:

“We are very pleased with the acceptance of our NDA submission and look forward to cooperating with the FDA on its review. We believe the quick dissolving film strip formulation of ondansetron offers a convenient and easy-to-administer option for managing nausea and vomiting associated with chemotherapy, radiotherapy and surgery.”

Tags: PRX

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