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Release issued 15th May 2009
FOR IMMEDIATE RELEASE
Palm Beach Gardens, Florida
On Thursday, May 7th, the U.S. Food and Drug Administration issued an emergency press release titled Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide (www.fda.gov/cder/drug/infopage/testosterone_gel/androgel.pdf ).
These new warnings were required because of numerous reports of secondary exposure or transference of the hormone to children, resulting in premature maturation and other deleterious effects. These conditions have been mostly reversible but in some cases the symptoms have not regressed and many children have undergone extensive diagnostic procedures and one child even endured surgery due to a delay in recognizing the underlying cause of the signs and symptoms.
Because of the unique formulation of the TDS® Testosterone which is extremely rapidly absorbed into the skin and the evaporation of any remaining TDS vehicle from the skin in minutes after dosing, the TDS system should not expect to be required to carry a warning or be burdened to provide documentation of extensive instructions for use as the risk of transference appears to negligible.
BACKGROUND - The inadvertent secondary exposures which precipitated the drastic action by FDA resulted from the fact that the AndroGel® and Testim® products remain wet in the skin for several hours after dose, leeching in slowly over the next 24 hours. If a family member presses on the skin or rubs the large areas of the upper body or the hands, during this 3-4 hour period, a significant dose of Testosterone will be transferred. Both companies were required to perform studies prior to approval to gauge the level of transference potential to intimate partners and both products proved capable of transferring sufficient hormone to raise serum levels in the partner. Consequently, both products already carried extensive warnings to avoid inadvertent skin-to-skin contact and instructions for protective measures to that end. The so-called "Black Box Warnings" and additional instructions represent a severe increase in the perceived danger of the product and likely will become a major barrier for these products. Since the notice was filed, the agency has reportedly been overwhelmed with calls reporting new cases of children and adults adversely affected. Internet traffic is high and personal injury attorneys are already advertising for potential plaintiffs.
TDS SYSTEM DEMONSTRATES ENHANCED SAFETY IN CLINICAL TRIALS - During phase 2 clinical trials comparing TransDermal's TDS-Testosterone to AndroGel, researchers swabbed the skin where the two products had been applied and analyzed the swabs for testosterone content. The analysis reported that even though the TDS-Testosterone product is 5 times more concentrated with hormone than AndroGel at application, the TDS system so efficiently delivers the hormone that it left only twice the amount of Testosterone Androgel showed at 30 minutes post dose and only about 40% of its 30-minute baseline after two hours. In comparison, the AndroGel-treated skin yielded more than 85% of its 30-minute baseline level at the two-hour post-dose swabbing.
While FDA have identified that it is not the presence of the hormone on the skin, but rather the presence of the hormone in the delivery vehicle that enables transference, it was noted in the study that the TDS-T treated skin was dry to touch in less than 10 minutes versus nearly 40 minutes on average for AndroGel. The peer-reviewed publication concludes in the Discussion section that the greatly reduced volume along with the rapid-drying characteristics of the TDS system will yield a more patient compliant product. http://www.Transdermaltechnologies.com/pdfFILES/TestosteroneBJCParticle.pdf
SAFER BY DESIGN - Company President and TDS-Testosterone co-inventor Kenneth Kirby commented that the TDS technology is designed to take its dose of hormone through the skin rapidly and once dry, in 5-7 minutes post dose, though some testosterone may remain on the skin, the TDS vehicle is gone and the remaining hormone is therefore incapable of transdermal delivery, and given the high metabolism of orally dosed Testosterone by the liver, enteral absorption resulting in transference was extremely unlikely.
"We have always believed along with our clinical opinion former, Professor Shern Chew, that the latency of the gel delivery vehicle in the skin represented a major risk and we designed this system to avoid this danger." At our preliminary meeting with FDA, we asked for a waiver from repeating the AndroGel transference protocol based on the Phase 2 swab data and the clearly elevated serum levels of hormone at the first time point 30 minutes after dosing, that dramatically exceeded AndroGel's levels. Substantial amounts of Testosterone clearly were off the skin and in the blood stream as intended. "While FDA rightly insisted on us performing the same transference safety study as was required for AndroGel and Testim as a part of our NDA submission, it is clear that low-to-no detectible transference levels would mean a safer as well as a less complicated product to use and a warning requirement such as is correctly imposed on these products would be an unlikely outcome for us," Kirby said.
CONTRIBUTING FACTORS: COMPLEXITY OF USE - The FDA's press release indicates that the major contributing factor to these inadvertent secondary doses was lack of patient compliance with the instructions to wait 30-40 minutes to dress while the gel dries sufficiently to not perfuse clothing and the necessity to wear a undershirt at all times over the application area. As the typical AndroGel dose is 10 grams it can be challenging to cover all the surface area required and the additional layer of clothing may not be well tolerated in warmer climes. Patient compliance as regards daily dosing regimens can be spotty and the added level of compliance required to safely use the product with a view to the potential for transference is seen to be problematical in this case.
A CLEAR STRATEGIC OPPORTUNITY - TransDermal has completed development of the TDS-Testosterone product through Phase 2 and there are two peer-reviewed journal articles in publication documenting the enhanced safety of the product due primarily to its rapid-drying nature and highly effective delivery mechanism which the gel products do not enjoy. The latest of these articles appeared in the International Journal of Clinical Pharmacology and Therapeutics in April 2009, describing TDS-Testosterone's superiority to AndroGel. The company is anticipating that the clear advantages of its TDS delivery system will be attractive to potential partners who can see this as a sustainable strategic opportunity in a large market somewhat cluttered with me-too products.
Industry analysts have agreed that as the TDS Testosterone product seems likely to avoid the requirement for the black box warning and increased compliance burden now imposed on AndroGel and Testim, and given the relatively short anticipated time to phase 3 approval, it is uniquely positioned to rapidly acquire a subtantial piece of the nearly $600 Million a year market, both here and in Europe. Given its enhanced safety and rapid-drying ease-of-use, consumers should naturally prefer this patented topical vehicle over the less convenient and potentially dangerous gels.
For Further Information, please contact:
Kenneth B. Kirby
If you want to find out more about the company visit TransDermal Technologies, Inc. profile.
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