Navigation Links
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 x 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, D harma in Seattle, WA. For further information, visit Dharma's website at: www.dharmatherapeutics.com

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

Web site: www.dharmatherapeutics.com

Terms and conditions of use apply
Copyright 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
2. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
3. CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa
4. Fat Kills Cancer: Turning Stem Cells from Fat Tissue into Personalized, Cancer-Targeted Therapeutics
5. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to Sustained Reductions in Blood Glucose Levels for 6 Months Post-treatment in Type 2 Diabetes Patients
6. Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study
7. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin for Multiple Sclerosis
8. Orexigen Therapeutics to Present Data on Contrave Impact on Visceral Fat and Insulin Resistance at American Diabetes Association 67th Scientific Sessions in Chicago June 23
9. Allos Therapeutics Reports Results for Phase 3 Enrich Study of Efaproxyn in Women With Brain Metastases Originating From Breast Cancer
10. Trophos Publishes ALS Article in Journal of Pharmacology and Experimental Therapeutics
11. Novelos Therapeutics Announces Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dana-Farber/Partners Cancer Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):