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Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial
Date:7/9/2009

SEATTLE, July 9 /PRNewswire/ -- Dharma Therapeutics, Inc., ("Dharma") Seattle, WA (a subsidiary of the Transcu Group Limited, a company listed on the Singapore Exchange Limited) announced that its improved active transdermal delivery technology, which administers lidocaine and epinephrine through the skin via a mild electric current, has demonstrated safety and efficacy in a Phase 2 clinical trial.

About the Trial:

The trial conducted was a Phase 2, double-blind, randomized, placebo-controlled, two-arm study evaluating the safety and efficacy of the administration of lidocaine and epinephrine using the IDDS to provide topical anesthesia in adults undergoing a venipuncture procedure. Eighty-nine (89) healthy volunteer subjects were treated at two clinical sites. The trial included subjects representing a wide range of ages and ethnicity. Subjects were randomized to receive an 8 minute administration of lidocaine plus epinephrine (Active arm) or epinephrine alone (Placebo arm) at the site of insertion of an intravenous catheter. After placement of the intravenous catheter, subjects evaluated their pain using the Visual Analog pain Scale (VAS) scoring system and were asked if they would use the IDDS again. Safety of the treatment was also monitored during the trial.

Results:

In the Per-Protocol population (including subjects completing 8 minutes of treatment) the mean Visual Analog pain Scale (VAS) results recorded by the subject following the venipuncture procedure were 16.4 mm for the Active treatment versus 24.0 mm for the Placebo treatment (p=0.0235). Therefore, the trial demonstrated statistically lower VAS scores for the Active group as compared to the Placebo group. In addition, more than 80% of the Active group reported pain elimination and willingness to undergo IDDS treatment again. The IDDS treatment was well tolerated, with no serious adverse event reported in any subject.

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SOURCE Dharma Therapeutics, Inc.
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