MONTREAL, Sept. 2 /PRNewswire-FirstCall/ -- 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