Transdermal Delivery Solutions Corporation (TDSC), www.TDSC.us, announced today entering a pivotal phase of clinical trials. The British National Health Service (NHS) Ethics filings (IRAS) preliminary to the Medicine and Health Products Review Authority’s (MHRA) approval of Clinical Trial Applications (CTA) for TDSC’s Investigational Medical Product Dossier on Hormone Replacement Technologies’ Testagen® HypoSpray® were filed on November 25th and 30th, 2015. NHS Ethics will review the protocols together on December 16th, 2015.
“We are pleased to reach this milestone and expect our progress with the technology to accelerate rapidly from here,” said Kenneth Kirby, President of TDSC. “As with any drug delivery FDA-approval process, it’s been a long road of regulatory channels over the course of its development. It’s exciting to begin this final stage of testing with TDSC.”
Professor Shern Chew and faculty from Barts & the London NHS at a partner facility, the Advanced Therapies Centre of the London Clinic, will perform the clinical trials. Scientific Advisors Professor Richard Langford, Professor Arthur Tucker, Professor Atholl Johnston and Professor Howard Maibach of UC San Francisco will oversee the research.
These initial studies in patients will establish the ideal initial dose range for following studies and validate earlier research that established HypoSpray technology’s greatly reduced potential for inadvertent transference to others. The CTAs are expected to be approved in 60-days or less and patient screening will begin immediately upon MHRA’s approval of the CTAs. These studies should be completed over the next 3-month period.
Testagen® TDS has been under evaluation for over ten years and is designed to address the safety problems associated transdermal and oral hormone replacement therapies. The FDA has released the product for trials both here and in the UK. The patented treatment formulation is expected to revolutionize testosterone replacement as the system provides faster absorption while avoiding liver interactions and dramatically lowers transferable concentrations left on the skin. http://www.tdsc.us/lower.php?url=testagen
About Low Testosterone
Low Testosterone or ‘Low T,’ also known as hypogonadism, is a condition in men characterized by the body’s failure to produce normal amounts of the hormone testosterone, a male sex hormone produced by the testes. Low T affects nearly 14 million men in the United States; yet only 9 percent (1.3 million) of men diagnosed with Low T are receiving treatment for the condition. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue, loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.
About Transdermal Delivery Solutions (TDSC)
TDSC is committed to advancing the science of transdermal drug delivery using its patented spray-on delivery system. TDSC’s proprietary system enables medications to be delivered directly through the skin, for systemic or localized application, utilizing its rapid acting, patchless, spray-on technology. The company’s technology is flexible enough to be applicable to a very wide range of compounds up to small peptides for pharmaceutical or cosmetic use. No other company can offer similar, consumer friendly, dosing flexible solutions.
About Hormone Replacement Technologies (HRT, Inc.)
HRT, Inc. is a subsidiary of TDSC that focuses on creating innovative, specific and medically current solutions impacting hormone replacement needs. www.HRTINC.com
Transdermal Delivery Solutions Corp.
Cindy Metzler, MarCom Consultant (for TDSC), 561-429-6429 (Headquarters)