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PRE-CLINICAL RESULTS ON TDS(tm) IBUPROFEN TRIALS ANNOUNCED

Release issued 15th June 2001

Lake Park, Florida - TransDermal Technologies, Inc. announced today the release of its latest pre-clinical data validating its patent-pending, patchless, liquid transdermal delivery system, TDS(tm) in the delivery of Ibuprofen.

The study, overseen by Prof. Derek Willoughby and completed by Dr. Chandan A.S. Alam, of the Department of Experimental Pathology of the William Harvey Institute at St. Bartholomew's and the Royal London School of Medicine and Dentistry, measured the ability of the TDS technology to deliver Ibuprofen across the skin in a sufficient dose to accomplish a therapeutic outcome without a patch or other appliance. Data from the study confirms company claims that the TDS technology enables rapid penetration and increased blood concentrations of Ibuprofen. This trial documents the fifth drug delivered successfully utilizing the TDS technology.

The model for the study was the white mouse and six different variations of TDS Ibuprofen were trialed. Each of the six formula variations were applied to 3 animals per formula. Blood samples were obtained at baseline, one hour and three hours. All six formulations were successful at delivering a dose of the drug with average blood levels at 18.6 micrograms per mL at 1 hour and 25.4 micrograms per mL at 3 hours. Some variations accomplished higher levels at one hour and lowered slightly by three hours. Others increased detectable levels between one and three and others started at high levels and remained at level through three hours. The company anticipates that additional kinetics may be obtained on the two most efficient formulas and therapeutic outcome studies are suggested by this data. This data is particularly encouraging in light of the fact that rats and mice metabolize Ibuprofen at a rate five times faster than human metabolism, but the TDS was nevertheless successful at achieving and maintaining a detectable blood level in the animals.

The need for alternative dosing capability as provided by transdermal means is particularly felt in the case of analgesics and narcotic pain relievers. Many patients poorly tolerate NSAIDs or non-steroidal anti-inflammatory drugs including ibuprofen due to gastro-intestinal distress and liver metabolism issues. Patients must be particularly careful about consuming alcohol with many of these drugs due to interactions between them. Narcotics, while highly effective pain relievers are also very dose-sensitive with potentially lethal side effects for over-dose. The TDS can effectively mitigate all of these issues with both NSAIDs and narcotics. The TDS accomplishes the therapeutic outcome that the drug is designed for with much smaller doses than oral equivalents as demonstrated in the company's successful pre-clinical studies of Morphine Sulphate. 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(tm) enables much safer narcotic dosing that virtually eliminates the possibility of overdose and greatly reduces tolerance- building that leads to addiction.

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

The TDS(tm) 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

Company details

If you want to find out more about the company visit TransDermal Technologies, Inc. profile.

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