Transdermal Delivery Solutions Announces Commencement of Clinical Trials of Hormone Replacement Technologies’ Testagen® 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 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
Contacts
Transdermal Delivery Solutions Corp.
Cindy Metzler, MarCom
Consultant (for TDSC), 561-429-6429 (Headquarters)
cindy@cindymetzler.com
