Transdel Pharmaceuticals, Inc.'s Ketotransdel (TDLP-110) effectively reduced pain intensity, with no serious adverse effects, according the the results of a Phase 3 Study presented at the 13th World Congress on Pain in Montreal, Canada.
Transdel Pharmaceuticals, Inc.’s Ketotransdel (TDLP-110) effectively reduced pain intensity, with no serious adverse effects, according the the results of a Phase 3 Study presented at the 13th World Congress on Pain in Montreal, Canada.
The company focuses on developing topically administered products using its proprietary transdermal delivery platform.
Ketotransdel utilizes the transdermal delivery platform to deliver the active drug ketoprofen, which is a non-steroidal anti-inflammatory drug. It is administered through the skin directly into the underlying tissues and exerts its anti-inflammatory and analgesic effects.
The data confirms:
- Patients treated with Ketoprofen 10% cream (TDLP-110) had statistically significant greater reductions in pain intensity than those treated with placebo.
- TDLP-110 cream demonstrated excellent safety and tolerability.
- No treatment related gastrointestinal, cardiac, liver or other serious adverse events occurred.
- No clinically relevant changes in blood and urine tests took place.
- Minimal blood concentrations of ketoprofen were detected in the pharmacokinetic (PK) sub-study.
“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, in a press release. “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.”