Release issued 30th May 2009

FOR IMMEDIATE RELEASE

Palm Beach Gardens, Florida

The U.S. FDA this week required marketers of NSAID drugs and Acetaminophen to add additional safety warnings to the labels of these products. The drugs targeted include Aspirin, Ibuprofen (Advil®, Neurophen®) Naproxen Sodium (Naprosyn®, Aleve®) Ketoprofen (Orudis®, Oruvail®), and of course Acetaminophen (Paracetemol) most broadly marketed under the Tylenol® brand of McNeil Consumer Products. The final rule applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers. Under the final rule, manufacturers must:
• ensure that the labeling warns of the risk of stomach bleeding for NSAIDs and the risk of severe liver damage for acetaminophen
• ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both packages and bottles
• revise the product labeling within one year of the date the rule was issued.

The warnings were particularly focused on Acetaminophen. Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing Acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risk of severe liver damage.

Alcohol use can also increase the risk of liver damage with acetaminophen. The risk of stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs or steroids at the same time. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

TransDermal Technologies has invested considerable resources in developing NSAID and Acetaminophen formulations utilizing the company's patented, sprayed onto the skin transdermal delivery system TDS. The company has formulated systems for Ibuprofen, Acetaminophen and Diclofenac (Sprayed on and semi-solid crème) and developed data on Ibuprofen and Acetaminophen.

A series of studies on Ibuprofen showed that the TDS system delivered the drug effectively and also had an anti-inflammatory effect. One of these studies was done to full GLP protocol where each sample was assayed by HPLC to ascertain that it contained the drug. Another study demonstrated the ability of the TDS to be modified to accomplish a different absorption curves with the same dose. A study of acetaminophen delivered with TDS demonstrated serum levels, pain modulation and brain levels. All of the studies are encouraging of development of these products.

The TDS technology offers significant benefits for consumers who require NSAIDs on a daily or weekly basis. The side effects of NSAIDS which precipitated FDA's warnings arise from the fact that the drugs are highly metabolised. As an example, Ibuprofen is only 10-12% bio-available. This is also true for Acetaminophen. As the typical recommended oral dose of Ibuprofen is 1,000 milligrams and the limit is 4,000 a day, a substantial amount of drug is in the gut and liver, available to create the side effects FDA warned about. The TDS formulations will only require about 10% of the drug, so instead of 4,000 milligrams, only 400 will be required for a day's relief. Ironically, the cardiovascular issues which have dogged the so-called COX II Inhibitors such as Celebrex® were engineered into the product formulations to make them tolerable to the stomach. TDS formulation, the only transdermal modality capable of rapidly delivering a sufficient bolus of drug to relieve pain and lower fever, could likely have avoided the patient injuries and deaths, subsequent warnings and in some cases, product withdrawals.

In the pediatric anti-fever applications, TDS will also provide a measure of added ease-of-administration for parents who have struggled to ensure that ill children take a full dose of an oral suspension. Parents will be able to spray on and rub in the child's dose potentially even as the child sleeps. The TDS technology will also enable combination therapies dispensed under prescription such as Diclofenac Sodium, Cyclobenzaprine (Flexeril®) and Lidocaine for muscle strain and pain, combining high level pain relief with muscle relaxant and nerve calming effects.

With all of the NSAIDs and Acetaminophen, by-passing the gut and the liver via transdermal delivery dramatically reduces the risk of overdose and the side effects that FDA has responded to this week. A product which provides the same level of pain relief much more rapidly than any oral formulation, enhanced ease-of-use, particularly in pediatric applications and at a fraction of the oral dose should enjoy the consumers' preference over oral dosing. By way of reference, TDS formulations are typically cost-competitive with tablets to manufacture.

TransDermal Technologies is seeking partners for these opportunities and looks forward to discussing the technology in detail. Data sets for the various studies can be made available under confidentiality agreements.

For more information contact:
Kenneth B. Kirby
mailto:K.Kirby@Transdermaltechnologies.com
001-561-429-6429

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