Changing Healthcare Worldwide


Release issued 04/05/2008

North Palm Beach, Florida

TransDermal Technologies announced today that senior members of company management met with representatives of the Center for Drug Evaluation and Research (CDER) at the offices of the Food and Drug Administration in Silver Spring, MD in early March 2008.

The company had requested a type B meeting preliminary to submitting documentation for IND status for a proposed phase III trial of TDS Testosterone, the company’s spray-on transdermally delivered product for male hormone replacement. A detailed clinical development plan was submitted prior to the meeting along with an investigator’s brochure, a proposed phase III protocol, preliminary Chemistry Manufacturing and Controls, Pharmacology and Toxicology and details on the company’s phase I and II trials completed at St. Bartholomew’s in London. The company was also keen to ascertain whether St. Bartholomew’s, the company's long-time clinical research collaborator would be an acceptable trial site and co-sponsor going forward. The agency signaled its approval of St. Bartholomew’s as an acceptable site.

The meeting was well attended by staff at CDER with 16 representatives from various disciplines as well as the Acting Deputy Director of CDER present. TransDermal received valuable input regarding the number of subjects and the duration of the trial expected for a phase III approval of a testosterone hormone replacement product and the agency’s expectation for a 6 month dermal toxicity protocol for the empty TDS delivery system was outlined. It was also agreed that a transference study evaluating how much Testosterone could be inadvertently transferred to a female partner from the skin of subjects using the TDS product would be useful. The agency agreed to work with the company to develop a protocol that would fairly evaluate the very fast drying nature and limited application area of the TDS product.

The company was particularly interested to get the agency’s evaluation of the excipients in the TDS delivery system. All but two were accepted as safe and for the two exceptions, the agency indicated it would accept existing toxicity and teratology data on the two ingredients that have not heretofore been included in an approved pharmaceutical product along with an opinion letter as to safety from a recognized expert.

The agency’s input was very informative and productive and the company now has established a collaborative relationship with FDA and can develop a clear path forward for generating the remaining data required for approval of the TDS Testosterone product. The company informed the agency that it intends to present the completed IND by November or December and hopes to start the phase III trial in the first quarter of 2009.

As a result of the input received from this meeting, the company expects to finalize arrangements for pre-production work to begin with a contract manufacturer who is licensed by FDA to produce alcohol-based Testosterone products. This manufacturer will transfer the company’s batch protocols into their system and produce trial batches which will undergo stability studies and dermal toxicity work in their laboratories.

TransDermal is actively seeking a licensing partner for development of this opportunity and is already in discussion with several companies about the opportunity. The potential market for transdermally delivered Testosterone exceeds $600 Million annually in the U.S. and the TDS Testosterone product is expected to take a large market share due to its ease and convenience of use as compared to the gel products currently available. TDS systems are routinely cost-competitive with tablets on a per-dose basis and expected to be approximately $0.08 per dose for the Testosterone application. In the case of existing Testosterone Gel products, TDS Testosterone offers a more rapidly absorbed, easier-to-use, more patient-friendly modality to apply a daily dose of hormone replacement to the skin. The product is rapidly dry on the skin, has a pleasant fragrance and in side-by-side dermal toxicity trials was less toxic than the approved gel products. In phase II trials, the product was deemed bio-equivalent to an approved gel product.

For more information contact

Ken Kirby