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Release issued 1st October 2004
LAKE PARK, FLORIDA - TransDermal Technologies, Inc. announced today the successful completion of the second phase of its clinical trial to validate its patented, patchless liquid transdermal delivery system, TDS® in the delivery of Testosterone. This third clinical study of the company's liquid transdermal delivery system TDS® in humans, was approved by North East London Ethics Committee and received DDX certification from The European Medicines & Healthcare Regulatory Authority in September 2003.
The study was completed by Dr. Chandan A.S. Alam, M.D. and Dr Arthur T. Tucker, PhD of the William Harvey Institute at St. Bartholomew's and the Royal London School of Medicine and Dentistry. The Langford Institute sponsors the study. The trial measured the ability of the TDS® technology to deliver testosterone through the skin as a topically applied hormone replacement without a patch or other appliance and maintain an increased serum concentration of testosterone over a twelve-hour window.
The completed first phase of this trial was a simple dose response trial of 5 single doses of Testosterone ranging from 10 to 50 milligrams delivered one each to 5 healthy volunteers. The results were supportive of progressing the trial to the next stage just completed - a Phase II b comparison of the TDS® system against a commercially available hydro alcohol gel system approved in the U.S. for testosterone hormone replacement therapy. In addition to comparatively evaluating the pharmacokinetics of the two systems, it examined safety by measuring residual hormone that remains on the skin. Gel systems commercially available in the U.S. must carry a safety warning to reinforce the dangers of flammability, reducing the total dose by washing off the drug which remains on the skin for up to 5 hours and the danger, during this latency of delivering a potentially harmful dose inadvertently by physical contact. TDS® is designed to rapidly and completely deliver the target drug or hormone within a few minutes of application. The study is designed to demonstrate the enhanced safety and efficacy of the TDS® over hydro alcohol gels.
This latest trial comes on the successful completion of the company's first and second human trials last year and this year that were completed in June and March respectively. The first trial tested the effectiveness of the TDS® in the delivery of Lidocaine as a venipuncture anesthesia intervention in 100 subjects. The second was the pilot phase of this trial. Drs. Alam and Tucker intend to seek publication of the results of this latest trial in a peer-reviewed journal. TransDermal intends to initiate a phase III market approval trial for Testosterone TDS® immediately.
Testosterone hormone replacement therapy is on the rise in both men and women due to recent studies establishing its safety in the treatment of Virapause and Menopause. Both injection, patch delivery and gel systems leave room for improvement, either in the necessity for regular injections, size of dose deliverable with patches or activity restrictions, which are imposed as safety precautions due to significant amounts of hormone remaining on the skin over hours with gels. These compliance challenges notwithstanding, sales of testosterone HRT products are growing incrementally and exceed $300 Million a year, with the advent of needle-less delivery. "A sprayed on, rapidly absorbed, convenient TDS® testosterone system incorporating incremental improvements, when proven safe and effective, should be rapidly approved for use and readily accepted by this growing market." Kirby said. The ability of the TDS® system to enable physicians to titrate the dose for hormone replacement to remedy more precisely the patient's serum hormone profiles, represents a major advancement in treating hormone disorders. Lack of flexibility in dosing has made pharmaceutical therapeutic intervention challenging for endocrinologists, who have been constrained to a one-or-two- dose-sizes-fits-all approach. "These results suggest that TDS® is a break through modality for hormone replacement dosing, both in its more natural pusatile absorption curve and its enhanced safety and convenience for users over other dose forms," said Kirby.
Transdermal drug delivery via the TDS® offers significant advantages. By bypassing the gut and first-pass liver metabolism, liver stress is eliminated or minimized. Also, as other clinical trials of the system have demonstrated, the TDS® can be modified to deliver a concentrated dose of drug 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. TransDermal Technologies has begun informing interested stakeholders in the hormone replacement segment of its interest in securing a partner or partners interested in exploiting this technology for testosterone.
The TDS® is a platform system that is modified to be specific to each application and has been proven to accomplish 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
If you want to find out more about the company visit TransDermal Technologies, Inc. profile.
(5th April 2008) TRANSDERMAL ANNOUNCES SUCCESSFUL DELIVERY OF DIAZEPAM THROUGH INTACT SKIN
(5th April 2008) TRANSDERMAL MEETS WITH THE CENTER FOR DRUG EVALUATION AND RESEARCH PRELIMINARY TO FILING AN INVESTIGATIONAL NEW DRUG APPLICATION FOR TDS® TESTOSTERONE
(15th June 2007) TRANSDERMAL TECHNOLOGIES WINS 3RD PATENT AWARD
(30th January 2006) TDS®-LIDOCAINE RECEIVES 2ND PEER-REVIEWED PUBLICATION
(20th December 2005) TDS®-TESTOSTERONE STUDY PUBLISHED IN PEER-REVIEWED JOURNAL