Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced positive top-line clinical results for its lead pain drug Ketotransdel®( )in a Phase 3 trial which 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 innovative proprietary Transdel(TM) drug delivery system.
Top-Line Results and Trial Design
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States.
The primary efficacy endpoint was the difference between Ketotransdel® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on Day 3. The VAS is a well known and validated instrument for pain measurement. 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 (the per protocol (PP) population) included a total of 252 patients and showed a positive and statistically significant outcome in the primary efficacy endpoint between Ketotransdel® and placebo, reaching a p-value of less than 0.05.
Secondary endpoints included safety assessments and other efficacy parameters.
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.
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.
Analysis of the Intent-to-Treat (ITT) population of the primary efficacy endpoint (which includes all study patients even if they failed to comply with the protocol and study requirements) favored Ketotransdel® compared to placebo but not to a degree that reached statistical significance. We believe that this finding was not due to a lack of effect of Ketotransdel®, but rather due to patient compliance issues, non-adherence to protocol procedures and other potentially confounding factors (e.g., incorrect use of study drugs and/or concomitant use of unallowed drugs).
"Based on these positive top-line clinical results and the excellent 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," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "In addition, this clinical study further validates the great potential of our proprietary transdermal drug delivery platform, and we look forward to maximizing the medical and commercial potential of this technology to bring important therapies to patients."
"There is a significant need among healthcare providers and patients for safe and effective therapies for pain management," said lead clinical investigator Evan F. Ekman, M.D. and President of Southern Orthopaedic Sports Medicine and Medical Director of Palmetto Health Parkridge Surgery Center. "The results from this Phase 3 clinical trial are very encouraging. They confirm to me that Ketotransdel® has a valuable role as a potentially safer and effective analgesic and anti-inflammatory treatment compared to available oral pain drugs, including oral NSAIDs, which are associated with gastrointestinal, cardiovascular and other medical problems."
Further detailed analyses are currently ongoing, and the Company intends to present the clinical trial results at upcoming medical conferences and in peer-reviewed journals.
The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel®, and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
SOURCE Transdel Pharmaceuticals, Inc.