SEATTLE, Oct. 24 /PRNewswire/ -- Dharma Therapeutics, Inc., ("Dharma") Seattle, WA, a transdermal drug delivery company and wholly owned subsidiary of Transcutaneous Technologies Inc. ("TTI"), Tokyo, Japan announced today the successful completion of their first human Phase 1 clinical trial using an active transdermal delivery technology known as iontophoresis, which administers lidocaine and epinephrine through the skin via a mild electric current.
The trial evaluated the safety of the iontophoretic drug delivery system, dermal patch and a direct current power source with lidocaine and epinephrine ("IDDS") at three dosage levels (as determined by the designed time of administration) to induce dermal anesthesia during a vascular access procedure (I.V. catheter insertion/venipuncture) in adult volunteers. A subset of the study was included to determine if lidocaine levels in plasma were detectable by standard clinical laboratory methods as well as the duration of anesthesia.
In this clinical study sixty (60) subjects evaluated the level of pain they experienced during venipuncture by rating their pain from 0 (no pain) to 10 (maximum pain imaginable). Evaluations were performed immediately following venipuncture in the untreated control arm and following intravenous I.V. catheter insertion in the treated arm after IDDS patch removal. Pain score evaluations from both scales resulted in statistically significant less pain for those who used the IDDS device, as compared to the control arm.
The IDDS has an excellent safety profile. During the trial, no significant adverse events were recorded. 3.3 % of the subjects (2 of 60) had mild adverse reactions and 1.7 % of the subjects (1 of 60) reported a moderate adverse reaction to treatment with the system.
The results of the trial and evidence show that administration of lidocaine and epinephrine is effective in reducing pain associated with a vascular access procedure for all dosing groups. Pain was eliminated using the IDDS and 80% of the subjects in the higher dosing groups would use the system again.
"The completion of our first Phase 1 clinical trial in the U.S. for the TTI/Dharma IDDS, represents a significant milestone," stated Steven G. Reed, Ph.D., President of Dharma. "It is an important step forward, and we believe our support for this technology will help advance needle-free drug delivery systems. We are pleased to see increasing evidence of our IDDS's excellent safety profile."
Lifetree Clinical Research(R) in Salt Lake City, UT conducted the Phase 1 clinical trial under an IND filed with the Food and Drug Administration (FDA), Division of Anesthesia, Analgesia and Rheumatology Products, Office of Drug Evaluation, Center for Drug Evaluations and Research ("CDER"). Lifetree Clinical Research(R) has earned a reputation for providing clinical trial support and management in the area of pain management. For further information, visit their website at: www.lifetreeresearch.com .
International Regulatory Consultants, L.C. ("IRC") a full service regulatory consultancy and specialty clinical research organization (CRO) also based in Salt Lake City, UT conducted this Phase 1 study. IRC offers global clinical development support for Phase 1-3 clinical programs. For further information, visit their website at: www.irclc.com .
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 Therapeutics, Inc. in Seattle, WA. For further information, visit their website at: www.dharmatherpeutics.com .
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Dharma Therapeutics, Inc.