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Dermatrends Human Study Shows Effective Transdermal Delivery Of Testosterone Using Improved Enhancer System


10/19/2005 5:10:01 PM

MINNEAPOLIS--(BUSINESS WIRE)--Feb. 12, 2004--Dermatrends, Inc.:

-- Human pharmacokinetic study showed effective delivery of testosterone in significantly smaller patch size than is now commercially available

-- Test is another in a sense of "in vivo" testing demonstrating success of Dermatrends unique enhancer system to deliver required therapeutic levels of multiple compounds

Dermatrends, Inc., a privately held research and development company devoted to transdermal and other drug delivery technologies, announced today that it had completed a successful randomized human pharmacokinetic and irritation study showing the effectiveness of testosterone delivery through the skin and into the bloodstream. The study further proves the effectiveness of Dermatrends technology to deliver required therapeutic levels of a commercially available compound. Further, the study showed that Dermatrends had favorable results compared with an existing commercial product in terms of effectiveness and permeation.

The test follows other in vivo tests by Dermatrends that show effective delivery of compounds that are not currently available commercially in transdermal delivery form. Dermatrends has also successfully tested multiple compounds on an in vitro basis using human cadaver skin (HCS), and its scientific team believes that the recent testosterone study, as well as prior tests, further indicates that many more compounds can be effectively delivered through the skin in the future. Today, fewer than 12 compounds are commercially available in transdermal form; testosterone is one of them.

Dermatrends Chief Executive Officer, Ted Schwarzrock, said, "We're very pleased with the results of this latest study. Our test data indicates that we should be able to effectively deliver the same or higher dosages of testosterone than are currently available and do so with smaller patch sizes. Assessment of test results indicates that a multi-day patch for testosterone could be developed."

Schwarzrock added, "The success of this in vivo study, combined with our significant past research and in vitro test results of compounds up to 1355AMU weight, give us great confidence that our technology can be used on many more compounds than are currently available. Our patented enhancer technology is truly a breakthrough in the field and we're very excited about working with partners in the pharmaceutical industry to bring this breakthrough into the commercial arena."

The subjects in the recently completed testosterone study were 12 post-menopausal women up to age 65. The test subjects were delivered 2.5 mg of testosterone across the skin with the Dermatrends patch delivering that dosage in a 12.5 cm2 patch.

The comparison control patch was the Androderm(R) patch (the product currently marketed by Watson Pharma, Inc.) delivering the same amount of testosterone, 2.5 mg in a larger 37 cm2 patch. The study subjects, post-menopausal women, were selected because they had no testosterone in their systems prior to the patch delivery of the compound so all testosterone found in the bloodstream could be accounted for by the transdermal patch delivery.

The study's scientists concluded that blood level studies of the subjects following patch delivery of the drug showed evidence that the Dermatrends system could be used as a multiple-day patch, and that a patch using the Dermatrends proprietary enhancer system could be developed to deliver 10 mg. of testosterone. Further, the company said its data supported the conclusion that a 25 cm2 patch of Dermatrends is expected to deliver 5 mg of testosterone across human skin while the size of 5 mg of Androderm is 44 cm2. The company said that further studies would be required to confirm the maximum dose and duration. Irritation levels were also studied and both the Dermatrends patch and the Androderm system were evaluated and found to be within acceptable irritation levels after the patch was applied for a 24-hour period.

The methodology of the study was a randomized, single blind, single center, crossover human pharmacokinetic study to compare the blood levels of testosterone as delivered from two transdermal systems and to evaluate skin irritation from those systems. The first phase included 12 women. Each of the two transdermal systems was randomly applied to six subjects. After one week, the 12 subjects crossed over between the Dermatrends system and the Androderm system. Blood sampling was performed over a 48-hour period after each dose. Test sites were photographed and evaluated for irritation at pre-dose, 30 minutes post-removal and 24 hours post-removal.

Dermatrends, Inc. is a privately held medical research and development company based in Minneapolis, Minn. with scientific laboratories in San Diego, California. The company is dedicated to the development of proprietary transdermal and other drug delivery technologies, and it has demonstrated an enabling platform technology that allows a broad variety of ethical and over-the-counter drugs to permeate the skin and mucosal surface at therapeutic levels in excess of anything currently commercially available. Additional information is available on the company's website at www.dermatrends.com. For further information on the company or for more information on this study, please contact 952-920-5383 or info@dermatrends.com .

For Media Information, contact Joanne Henry at 612-843-2142.

Contacts

Dermatrends, Inc., Minneapolis Joanne Henry, 612-843-2142


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