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
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