Transdermal Delivery Solutions Announces Regulatory Approval of Clinical Trials Commencement of Test
Tuesday, April 19, 2016
April 19, 2016
Transdermal Delivery Solutions Announces Regulatory Approval of Clinical Trials Commencement of Testagen® Topical Testosterone HypoSpray®
Transdermal Delivery Solutions, a leader in the development of spray-on drug delivery systems, announced today they are entering the pivotal phase of clinical trials
PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Transdermal Delivery Solutions Corporation (TDSC) www.TDSC.us announced today the receipt of its releases to begin its pivotal phase of clinical trials. The British National Health Service (NHS) Ethics filings (IRAS) and approval of Clinical Trial Applications (CTAs) for TDSC's Investigational Medical Product Dossier on Hormone Replacement Technologies' Testagen® HypoSpray® were filed in November,2015. NHS Ethics reviewed the protocols together on December 16th, 2015 and the Clinical Trial Applications were then finalized in mid-February and filed with the Medicine and Health Products Review Authority's (MHRA)for their final review and approval, which is provided in the Notices of Acceptance of Amended Request received today.
"We are pleased that NHS Ethics and MHRA have responded so quickly to move us forward towards this next critical milestone. We expect to initiate patient screening within a few weeks," 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, complicated by having to repeat the process in the UK under EMEA protocols as well. It's an exciting milestone to reach in this final stage of validating the Testagen® Testosterone HypoSpray®, which we expect to out-perform the competition."
Professor Shern Chew and faculty from The London Clinic Advanced Therapies Centre 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 audit and oversee the research. "We are pleased and honored to have the commitment and sterling clinical input of The London Clinic as well as Prof. Tucker, Dr. Enrico Pagani and the team from Seahorse Scientific Services who are acting as our UK sponsor for the studies," said Kirby.
These initial studies in patients will establish the ideal dose for following studies and validate earlier research that established HypoSpray technology's greatly reduced potential for inadvertent transference to others. These studies should be completed over the next 3-4 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. https://www.youtube.com/watch?v=Ff-1z1SYoF8
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.
Company: Hormone Replacement Technologies, Inc. : www.HRTINC.com
About The London Clinic
Leading Consultants, Compassionate Care, Traditional Values Founded in 1932, we are a charitable hospital with only the best patient care in mind. We strive to provide world-class medical expertise; combining knowledge and technology with integrity and compassionate care.
Transdermal Delivery Solutions Corp.:
MarCom Consultant (for TDSC)
Cindy Metzler, 561-429-6429
The London Clinic
Lizzie Toop, 020 3219 32870