Transdel initiates Phase III study of topical pain drug

The company has engaged Cato Research, a global contract research organization (CRO), as a strategic partner and as the CRO to conduct the Phase III clinical program.

The company’s randomized, double-blind, placebo controlled Phase III trial will evaluate the efficacy and safety of Ketotransdel for the topical treatment of acute pain from soft tissue injuries. Clinical sites are planned throughout the US and potentially other regions, including Canada.

The company expects that Ketotransdel, if approved by the FDA, could become the first topical non-steroidal anti-inflammatory drug (NSAID) cream product in the US for acute pain management.