Transdel Reports Positive Phase 3 Results For Ketotransdel

Transdel Pharmaceuticals (Transdel) has reported positive top-line clinical results for its lead pain drug, Ketotransdel, in a phase 3 trial. The study evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities.

Ketotransdel is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the company’s proprietary Transdel drug delivery system.

Reportedly, the double-blind, randomised, placebo-controlled, multi-center phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the US.

The primary efficacy endpoint was the difference between Ketotransdel and placebo in the change from baseline in pain intensity as measured by the 100mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on Day 3.

The result suggested that the study achieved statistical significance in its primary endpoint in the per protocol analysis. The statistical analysis of those patients that complied with the study requirements included a total of 252 patients and showed a positive and significant outcome in the primary efficacy endpoint between Ketotransdel and placebo, reaching a p-value of less than 0.05.

The company said that Ketotransdel demonstrated an excellent safety and tolerability profile similar to the placebo cream. In particular, there were no Ketotransdel treatment related gastrointestinal, cardiovascular or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.

It also showed that Ketotransdel was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent pharmacokinetic (PK) assessments following multiple exposures during the study. These PK results are consistent with the company’s previous clinical study findings.

The company is seeking a commercial partner for Ketotransdel, and is actively pursuing discussions with US and foreign based potential partners with sales and marketing infrastructures.

Juliet Singh, president and CEO of Transdel, said: “Based on these positive top-line clinical results and the safety profile demonstrated, we believe Ketotransdel is well-positioned to address a critical need in the pain management marketplace. We are committed to continue working closely with the FDA to bring this much needed drug to the marketplace as soon as possible. In addition, this clinical study further validates the great potential of our proprietary transdermal drug delivery platform, and we look forward to maximising the medical and commercial potential of this technology to bring important therapies to patients.”