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Dharma Therapeutics Shows IDDS Is Effective in Reducing Pain,,,Associated With Insertion of an Intravenous Catheter in Their Phase,,,2 Clinical Trial

Iontophoretic Drug Delivery System, dermal patch and a direct current power source with lidocaine and epinephrine (IDDS)

SEATTLE, March 20, 2007 /PRNewswire/ -- Dharma Therapeutics, Inc., ("Dharma") Seattle, WA, a transdermal drug delivery company and wholly owned subsidiary of Transcutaneous Technologies, Inc. ("TTI"), Tokyo, Japan announced that its active transdermal delivery technology, which administers lidocaine and epinephrine through the skin via a mild electric current, was safe and effective in delivering topical anesthesia in 8 minutes.

About the trial:

The trial was a Phase 2, double-blind, randomized, placebo-controlled, two-arm study evaluating the safety and effectiveness of the administration of lidocaine and epinephrine using the IDDS to provide topical anesthesia in adults undergoing a venipuncture procedure. Seventy one (71) healthy volunteer subjects ranging in age from 18 to 57 years old were treated at a single clinical site. Subjects were randomized to receive an 8 minute administration of lidocaine plus epinephrine (Treatment Arm) or epinephrine alone (Placebo-Control Arm) at the site of insertion of an intravenous catheter into the posterior surface of the subject's hand. After placement of the intravenous catheter, subjects evaluated their pain using the VAS scoring system and were asked if they would use the IDDS again. Investigators also evaluated the subjects' level of pain and whether or not IDDS treatment was acceptable to the subjects. Safety of the treatment was also monitored.

Results:

Median VAS scores were reduced by 58%, a highly significant reduction in perceived pain (p < / = 0.01). The majority of subjects in the Treatment Arm reported elimination of their pain, while only a minority of subjects in the Placebo-Control Arm reported pain elimination (p < 0.05). Thirty-four of thirty-si
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