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
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.
CONTACT: Paul R. Sleath, Ph.D., President and
CEO of Dharma
Therapeutics, Inc., +1-206-330-2591, psleath@dharmatherapeutics.com
Therapeutics, Inc., +1-206-330-2591, psleath@dharmatherapeutics.com
Web Site: http://www.dharmatherapeutics.com/
