Dharma Therapeutics, Inc. 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.
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.
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.