Transdel Completes Enrollment In Phase-III Pain Trial

Transdel has completed the enrollment of patients in pivotal phase-III clinical study for Ketotransdel, a topical cream-based non-steroidal anti-inflammatory drug (NSAID) for acute pain.

Moreover, the company expects that Ketotransdel, if approved by the FDA, could become the first topical NSAID cream product in the US for acute pain management.

The phase-III clinical study is a randomized, double-blind, placebo controlled trial, to evaluate the efficacy and safety of Ketotransdel. Over 350 patients were enrolled at approximately 30 centers throughout the US.

The company also plans to pursue FDA approval of Ketotransdel for other indications, such as osteoarthritis.

Juliet Singh, President and CEO of Transdel, said: “Completion of enrollment for the pivotal Phase 3 clinical study is a significant milestone in the development program for Ketotransdel. We look forward to reporting the top-line results later this quarter, as previously announced.”