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news.Transdel Pharmaceuticals has announced that based on the FDA's review of its Phase III submission, the company can initiate its Phase III clinical program for its novel topical cream based non-steroidal anti-inflammatory drug, Ketotransdel.
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In the second quarter of 2008, the company intends to initiate the randomized, double-blind, placebo controlled Phase III program to evaluate the efficacy and safety of Ketotransdel in acute pain care management. The company also stated that in the near term it will be announcing organizational changes as the company transitions into late stage clinical phase.
Juliet Singh, president and CEO of Transdel, said: “I am pleased to announce that the FDA has reviewed our February 7, 2008 FDA submission and has stated that it is safe to proceed with the Phase III program. The FDA also noted that there are no clinical hold issues and provided comments regarding the registration requirements of our lead drug.”