Changing Healthcare Worldwide

TDS SUCCESSFULLY COMPLETES DERMAL TOXICITY EVALUATION

Release issued 02/20/2013

PALM BEACH GARDENS, Fla. (February 20, 2013) --- Transdermal Delivery Solutions Corporation (TDSC), a company specializing in the development of unique patchless, metered pump, sprayon drug delivery technology and products, announced that it has successfully completed an indepth safety evaluation of its TDS transdermal drug delivery system. The system enables medications to be delivered through the skin, for systemic or localized application, utilizing its proprietary, spray on technology. Designed to be rapidly and completely absorbed by the skin, the system consequently limits the potential for irritation or transference to others.

TDSC researchers worked closely with the FDA Division of Reproductive and Urological Products (DRUP), to design the evaluation study to assess the safety of the individual ingredients, as well as the system as a whole. The study was conducted over a 21 day period where 32 subjects were exposed to each of the excipient ingredients found in the TDS drug delivery system. On a daily basis, the subjects were evaluated then re-challenged using the test materials. After close clinical monitoring the subjects’ reactions over the course of the study, researchers were able to conclude that the system was neither toxic nor irritating to the skin.

“The results of this study are very encouraging as we continue to focus our efforts on developing a safer and more efficient method of transdermal drug delivery”, said Kenneth Kirby, CEO of TDSC. “Existing gel transdermal technologies have significant health risks, and this study is testament to the competitive safety advantage our technology holds in this market.” These findings are especially promising in the advancement of TDSC’s first product, a transdermal testosterone system, Testagen™. The same batch of test materials will be used in the product’s clinical trials later this year. Testagen™ TDS® is a revolutionary topical testosterone application that provides faster absorption, lower concentrations left on the skin, and the ability to micro-adjust the dose for individual patient needs, as well as meaningfully addressing the health risk of transference.

The TDS transdermal delivery system’s toxicology study report will be submitted to FDA along with extensive data on the safety of all the excipients. This will allow for the FDA to proceed with their own safety evaluations of the system, with the imminent initiation of a Phase III trial that will extend for a full 6 months of daily exposures.