The company plans to initiate randomized, double-blind, placebo controlled Phase III clinical trials for the efficacy and safety of Ketotransdel in acute pain care management, following the FDA’s 30-day review period. The company plans to begin the trial in the second quarter of 2008.
Juliet Singh, president and CEO of Transdel, said: “The filing has addressed all of the items that were requested by the FDA at a previous meeting between the company and FDA personnel. These items included the proposed Phase III clinical protocol, the completed non-clinical studies and detailed manufacturing information.”