Transdel Pharmaceuticals presents Ketotransdel Phase 3 data at 13th World Pain Congress

Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, announced today the final data set from its Phase 3 study of Ketotransdel® (TDLP-110) at the 13th World Congress on Pain in Montreal, Canada.  TDLP-110, the Company's lead pain product candidate, utilizes its transdermal delivery platform to deliver the active drug ketoprofen, a non-steroidal anti-inflammatory drug, through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects.

The complete analyses of the Phase 3 data confirm that:

• Ketoprofen 10% cream (TDLP-110) treated patients had statistically significant greater reductions in pain intensity than placebo treated patients;
• TDLP-110 cream demonstrated excellent safety and tolerability;
• There were no treatment related gastrointestinal, cardiac, liver or other serious adverse events;
• There were no clinically relevant changes in blood and urine tests;
• Minimal blood concentrations of ketoprofen were detected in the pharmacokinetic (PK) sub-study, supporting the excellent safety profile of TDLP-110.

"The data of the TDLP-110 Phase 3 trial confirm that it is an effective product candidate for reducing pain of acute soft tissue injuries and is very well tolerated," said lead clinical investigator Evan F. Ekman, M.D. and President and Medical Director of Southern Orthopaedic Sports Medicine, Columbia, SC. "TDLP-110 has the potential to offer a new standard in topical pain management with an active ingredient and an elegant cream formulation that once approved differs from available topical NSAID treatments. In particular, I am impressed by the excellent cutaneous/application site tolerability."

The presented poster titled "EFFICACY AND SAFETY OF KETOPROFEN 10% CREAM IN THE TREATMENT OF PAIN ASSOCIATED WITH ACUTE SOFT TISSUE INJURIES (PHASE 3 STUDY TDLP-110-001)" summarizes the key efficacy data from Intent-to-treat (ITT) analysis and safety data of all patients randomized. In agreement with statistical (ICH-E9) guidelines a total of 35 patients were excluded from the original ITT population of 361 patients since they did not meet study entry criteria and should not have been enrolled based on information that was not known at the time of enrollment.  This modified ITT (mITT) population included 326 patients.

Using the primary endpoint, which was the change from baseline in pain intensity during daily activity over the previous 24 hours at the Day 3 visit, the study demonstrated statistical significance.

The proportion of patients who were satisfied with the treatment and achieved moderate or higher pain relief - as recorded on a seven-point Likert Scale - was greater with TDLP-110.

TDLP-110 demonstrated excellent safety and tolerability with a low overall incidence (18.1% vs. placebo 20.3%) of adverse events (AEs) and no treatment related gastrointestinal, cardiovascular, hepatic or other clinically relevant AEs. The incidence of related cutaneous/application site adverse events was slightly lower with TDLP-110 (1.1% vs. placebo 2.2%, respectively). There were no clinically relevant shifts from baseline in laboratory parameters (hematology, coagulation, serum chemistry, and urinalysis). The estimated systemic absorption of TDLP-110 is about 1 - 2 % of a comparable oral ketoprofen dose. In a pharmacokinetic sub-study of this Phase 3 trial minimal blood concentrations (mean Cmax 39.0 ng/mL) of ketoprofen were measured at steady-state, which is consistent with previous Phase 1/2 study findings. This Phase 3 study (TDLP-110-001) demonstrated that TDLP-110 was more effective than placebo in reducing pain of acute soft tissue injuries and was very well tolerated.

"Today's presentation of our data at the world's premier congress devoted to research and treatment of pain is a significant event for our company," stated Joachim Schupp, M.D., Chief Medical Officer at Transdel Pharmaceuticals. "We believe that study TDLP-110-001 could serve as one of two required confirmatory trials of evidence of efficacy for TDLP-110 and we plan to initiate the second trial upon sufficient funding."