Dharma Therapeutics Shows IDDS Is Effective in Reducing Pain,,,Associated With Insertion of an Intravenous Catheter in Their Phase,,,2 Clinical Trial
xsubjects (94%) in the Treatment Arm reported that they would use... We are very encouraged and pleased that we have been able toconfir...TTI is a biotechnology company focused on drug delivery usingits ID...
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
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