Navigation Links
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.

"This represents a major advancement for Dharma and the Transcu Group," said Paul R. Sleath, President and CEO of Dharma Therapeutics. "We are very excited about this product and the improvements over Dharma's prototype evaluated in earlier clinical trials. Our current design is very user friendly and can be manufactured cost efficiently at commercial scale. We believe our product will be highly attractive to consumers, as it has been designed to meet the market demand for a low cost, fast onset local anesthesia product."

Dharma has an end-of-phase 2 meeting scheduled with the Food and Drug Administration for this fall and plans to embark on pivotal Phase 3 trials in early 2010.


'/>"/>
SOURCE Dharma Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Cardiogenesis Announces Presentation of its PHOENIX(R) Combination TMR Plus Stem Cell Delivery System at the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) Annual Meeting
2. New Study Suggests Rx Estrogen Delivery Through the Skin May Show Safety Benefits as Opposed to Oral Delivery
3. Michael J. Fox Foundation Awards $2.1 Million to Improve Drug Delivery in Parkinsons Disease
4. DSM Obtains Exclusive World-Wide License for Innovative Drug Delivery Technology
5. Human Genome Sciences Begins Delivery of First-in-Class Anthrax Treatment to U.S. Strategic National Stockpile
6. Reproductive Partners Participates in New IVF Progesterone Delivery System Study
7. Jennerex Completes the Treatment of First Patient Cohort in Phase 1 Trial With Intravenous Delivery of JX-594 Oncolytic Virus
8. CEL-SCI Expects to Take Delivery of New Manufacturing Facility on October 8, 2008
9. Oramed Pharmaceuticals Launches GLP1-Analog Program, Based on its Proprietary Drug Delivery Platform
10. (RED) to Launch New Way for People to Get Music in Their Lives; Weekly Delivery of Great Music Helps to Save Lives in Africa
11. Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G - Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Patients With Progressive Chemo-Resistant Bone and Soft Tissue Sarcoma (ASCO 2008)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... Oct. 11, 2017  BioPharmX Corporation (NYSE MKT: BPMX) ... developed an innovative way to use nonlinear optical imaging ... of new drugs. ... Conference will show how researchers from BioPharmX and the ... School used a suite of imaging techniques in what ...
(Date:10/11/2017)... -- Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided an ... Puerto Rico , where the company ... Following a comprehensive onsite assessment, ... damage, temporary loss of power and minimal water damage ... operations have resumed, and the company expects to return ...
(Date:10/7/2017)... Oct. 6, 2017   Provista, a proven ... $100 billion in purchasing power, today announced a new ... The Newsroom is the online home for ... infographics, expert bios, news releases, slideshows and events. ... a wealth of resources at their fingertips, viewers can ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Dickinson Insurance ... insurance and financial preparation services, is providing an update on a charitable event ... Rock City Rescue is a locally recognized nonprofit that provides shelter and care ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... certification process to promote standards of excellence for the field of eating disorders, ... March 22 – 25, 2018 in Orlando, Florida at the Omni Resort at ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes ... of the facility as part of a disaster drill on October 3rd. , Apple ... Shelton City Emergency Manager, as well as the Connecticut Long Term Care Mutual ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Global Healthcare ... scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare ... activity. The fun run is geared towards children of all ages; it is ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to ... to save lost souls in the Philippines. “The Journey: From the Mountains to the ... teacher of the Bible. She has taught all ages and currently teaches a class ...
Breaking Medicine News(10 mins):