You may recall a little over a year ago Endo Pharmaceuticals (NASDAQ: ENDP) acquired RxKinetix whose lead product was RK-0202, a topical oral-rinse with the active ingredient formulated in its proprietary ProGelz® drug delivery platform and was in Phase II.
It sounds as if great progress is being made on RK-0202 which subsequently has become EN 3285. Endo announced that it will initiate the first of two Phase III clinical studies late in 4Q07 for EN 3285, for the prevention or delay of severe oral mucositis (OM), painful mouth sores that often occur in cancer patients undergoing radiation and chemotherapeutic treatment. Endo has agreed to the trial design with FDA under the Special Protocol Assessment (SPA) process. Under the terms of the SPA, Endo will initiate a multi-center, double-blind, placebo-controlled trial in approximately 240 OM patients undergoing chemoradiation therapy for head and neck cancer. The primary endpoint will be total radiation dose to onset of severe OM. A second Phase III study is expected to begin during the first half of 2008. The FDA will require two Phase III, double-blind, placebo-controlled trials as the basis for an NDA for this indication. As such, the company is currently projecting a 2010 NDA filing date for this product but may provide future updates depending upon the pace of patient enrollment in the clinical trials.
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