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


3/20/2007 12:08:11 PM

SEATTLE, March 20 /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-six subjects (94%) in the Treatment Arm reported that they would use the IDDS again compared to 21 out of 34 subjects (62%) in the Placebo-Control Arm (p = 0.001). In addition, investigators reported that 34 out of 36 subjects (94%) in the Treatment Arm found the IDDS treatment acceptable, which was significantly higher than the Placebo-Control Arm (p < 0.01). Following treatment with placebo, 44% of subjects reported moderate to severe pain (VAS score > / = 30) while only 8% of the subjects in the Treatment Arm reported moderate pain. The treatment was safe and well-tolerated with no significant adverse effects reported in any subject. Further, the iontophoresis procedure was successfully completed in all subjects in the Treatment Arm.

"We are very encouraged and pleased that we have been able to confirm the results of our Phase 1 clinical study that was completed in September 2006. In our current Phase 2 trial we have demonstrated in a randomized placebo controlled study that brief treatment with the IDDS is capable of providing significant pain relief to subjects undergoing intravenous catheterization," said Darrick A. Carter, Ph.D., Vice President of Research and Development at Dharma. "Moreover, nearly all subjects were reported to find the IDDS acceptable treatment demonstrating not only its therapeutic effects, but overall acceptability for administrating topical anesthesia. Given these results, we are intensifying and expanding our development efforts to study the potential clinical efficacy of the IDDS in other applications. We plan to rapidly initiate a clinical trial evaluating the IDDS to provide local anesthesia for patients undergoing dermatological procedures and development for Phase 3 pivotal studies is underway."

TTI is a biotechnology company focused on drug delivery using its IDDS technology. TTI conducts research at its headquarters in Tokyo, Japan and at its subsidiary, Dharma in Seattle, WA. For further information, visit Dharma's website at: www.dharmatherapeutics.com

Dharma Therapeutics, Inc.

CONTACT: Darrick A. Carter, Ph.D., Vice President, Research andDevelopment of Dharma Therapeutics, Inc., +1-206-330-2583, orprmedia@dharmatherapeutics.com



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