FDA clears Transdel's Ph III Ketotransdel studies

The USA's Transdel Pharmaceuticals says that the Food and Drug Administration has cleared the Phase III clinical program for its novel topical cream-based non-steroidal anti-inflammatory drug, Ketotransdel. The FDA noted that there are no clinical hold issues and provided comments regarding the registration requirements of the firm's lead drug.

Based on industry estimates, the market for NSAIDs and COX-2 inhibitors exceeds $6.0 billion per year, with more than 30 million people worldwide using NSAIDs daily. Due to the recognition of known risks associated with orally-administered NSAIDs, including cardiovascular, gastrointestinal and other medical complications, and the decline in the use of COX-2 inhibitors because of safety concerns, Transdel believes that there is a significant demand for topical pain management products such as Ketotransdel. Moreover, the firm expects that the agent, if approved by the FDA, could become the first topical NSAID cream product in the USA for acute pain management. The drug could address a significant unmet medical need for patients with medical conditions and those seeking safer alternatives to the standard pain management approaches.