Dharma Therapeutics’ IDDS Shows Desired Results

Dharma Therapeutics’ 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 was a phase 2, double-blind, randomized, placebo-controlled, two-arm study. It was to evaluate the safety and efficacy of the administration of lidocaine and epinephrine using the IDDS, to provide topical anesthesia in adults undergoing a venipuncture procedure. Over 89 healthy volunteer subjects were treated at two clinical sites, said the company.

Subjects were randomized to receive an 8 minute administration of lidocaine plus epinephrine or epinephrine alone, 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 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.

Paul Sleath, President and CEO of Dharma Therapeutics, said: “This represents a major advancement for Dharma and the Transcu Group. 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.”