Release issued 12th June 2003

LAKE PARK, FLORIDA - The first clinical human study of the company's liquid transdermal delivery system TDS®, was overseen by Prof. Derek Willoughby and completed by Dr. Chandan A.S. Alam, M.D. of the Department of Experimental Pathology and Dr Arthur T. Tucker, Ph.D of the William Harvey Institute at St. Bartholomew's and the Royal London School of Medicine and Dentistry. The study was sponsored by the Langford Institute. The trial measured the ability of two different formulations of the TDS technology to deliver a combination of drugs to the skin without a patch or other appliance, as a topically applied anesthetic intervention. The trial was completed June 10th, 2003.

One hundred healthy volunteer subjects were recruited and successfully completed the study according to ICH-GCP guidelines. On each visit the subjects had an initial baseline blood sample drawn and then received a spray of test material on one hand and a spray of placebo on the opposite hand. After 5 minutes, a needle was inserted into each hand in turn, removed and the wound dressed. The patient was asked to rate the pain in each hand from the procedure using clinically accepted VAS and VRS scales. After 2 hours, blood was drawn to analyze for the level of drug in the circulatory system. Preliminary analysis indicates a reduction in pain scores associated with the TDS® anaesthetic formulation, indicating transdermal pharmaceutical delivery. Serum analysis is pending. There were no reported significant side effects and the test materials were well tolerated by all subjects.

The trial, began last September and was carried out with the consent of the North East London Ethics Committee and DDX certification from the British Medicines Control Agency.

Ultra-rapid, reliable dermal anesthesia would represent a tremendous break-through. While many patients can tolerate injections and venipuncture procedures, the use of injected lidocaine as an anesthetic prior to minor surgery is itself a painful procedure, entails a needle stick, another bio- hazardous sharp instrument to dispose of, and a 20 minute delay before the procedure can be performed. The need for alternative dosing capability for topical anesthetics as provided by transdermal means is particularly felt in pediatric environments where children may have to endure multiple sticks over a short period of time. While topical lidocaine preparations exist, they routinely require 45 minutes to an hour for onset of anesthesia and then are only effective for approximately 60% of the patients. This long delay and unsure outcome typically increase anxiety for patients already anxious about the day's procedures. Additionally, existing topical anaesthesia formulations are of no use in acute scenarios.

The TDS® has now proven that it can mitigate these issues with a topical anesthesia. In this trial the TDS® system met the primary study outcome.

With the success of this trial, TTI will be seeking approval to begin pediatric trials at major pediatric centers.

By bypassing the gut and first-pass circulation from the gut to the liver, GI distress and liver metabolites are eliminated or minimized. The TDS® can be modified to deliver a concentrated dose to a local area, which is not broadly distributed throughout the body. This capability, coupled with the smaller doses possible with the TDS® enables much safer dosing that virtually eliminates the possibility of overdose and greatly reduces tolerance-building tendencies.

TransDermal Technologies is actively seeking a licensing partner or partners interested in exploiting this technology.

The TDS® is a platform system that is designed to be modified for each application and is believed to enable the rapid, safe and effective delivery of many medicaments across intact skin by means of its sprayed on or applicator applied lotions.

Company Contact: Kenneth B. Kirby - K.Kirby@Transdermaltechnologies.com / 800-282-5511 / 561- 848-9100

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