Transdermal Delivery Solutions Subsidiary, Hormone Replacement Technologies, Receives FDA Approval to Begin Pivotal ...

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PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--

Transdermal Delivery Solutions Corporation (TDSC) announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application submitted by its subsidiary, Hormone Replacement Technologies. Under the IND, Hormone Replacement Technologies will conduct several clinical trials of Testagen TDS for the treatment of low testosterone in men, including Phase I and Phase II dosing studies, Phase II study investigating transference, and a Phase III comparative analysis.

Specifics of each study include:

1. Dose Range Study a one-week dose finding study to determine the optimal dose that is high enough to demonstrate efficacy in the target population.

2. Transference Study aimed at measuring the potential of Testagen TDS to be inadvertently transferred to family members, which is a major concern for topical testosterone products currently on the market. This study is designed to validate TSDCs claims that Testagen TDS, which dries on the skin in 5-10 minutes after application, cannot be readily transferred to others.

3. Comparative Study expected to begin in the fourth quarter, the most pivotal of the three studies, involves a 90-day evaluation of patients using Testagen TDS to measure the response compared to patients using gel testosterone preparations. Upon completion, one third of the 150 patients in this study will be randomly selected to continue using Testagen TDS for a full six-month evaluation period.

There are nearly 14 million men in the United States suffering from low testosterone, which can lead to more serious illnesses, yet only 1.3 million (9 percent) are currently being treated, said Chandan A.S. Alam, MD, executive vice president and Chief Science Officer for TDSC. There are currently product safety issues with all existing forms of transdermal testosterone hormone replacement, including site-of-application reaction to patches and roll-on gels, as well as dangers associated with inadvertent dosing to third parties by contact with gel preparations remaining on the skin. To this end, there is a great need for new and novel treatment options, added Dr. Alam.

The studies will be conducted by experts in the field of hormone replacement and transdermal delivery of drugs at St. Bartholomews Royal London School of Medicine (Barts and the London NHS). Recruiting for the first study is al-ready underway.

Testagen TDS has been under evaluation for over ten years and is designed to address these problems of transdermal hormone replacement therapies. The patented treatment formulation is expected to revolutionize topical testosterone application as the system provides faster absorption and lowers transferable concentrations left on the skin.

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Transdermal Delivery Solutions Subsidiary, Hormone Replacement Technologies, Receives FDA Approval to Begin Pivotal ...