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Transdel Pharmaceuticals Presents Phase 3 Study Data on Ketotransdel® at World Pain Congress in Montreal, Canada

September 2, 2010 By Bio-Medicine.Org

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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SOURCE

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