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Transdel Pharmaceuticals Presents Phase 3 Study Data on Ketotransdel® at World Pain Congress in Montreal, Canada
Date:9/2/2010

, 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 (p=0.038) in the mITT population and approached statistical significance (p=0.087) in the original ITT population. Pain during activity scored 3 times daily by patients over seven days also supports the primary endpoint by demonstrating a consistent separation between the TDLP-110 and placebo groups over time, and showed statistical significance between the two groups in the ITT analyses.

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 (p=0.023). Time to onset of meaningful pain relief was assessed and was about 40 minutes faster in TDLP-110 treated patients.  Time to end of meaningful analgesic effect was about 45 minutes longer in the TDLP-110 treated group.  

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
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SOURCE Transdel Pharmaceuticals, Inc.
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