Overview

Male hypogonadism, goes by many names ("Low T", "Andropause" and "Male Menopause") and refers to age-related reduction of circulating endogenous testosterone.  On average, a 50-year-old male will produce approximately half the testosterone they once had at age 25.  Symptoms of Low T include diminished libido, fatigue and irritability.  Low T is often misdiagnosed as a host of other maladies, including depression and erectile dysfunction.  It is conservatively estimated that Low T affects 13 million American men, up to 90% of whom go untreated.  Current treatment guidelines focus on the restoration of the physiological testosterone level through the use of exogenous testosterone preparations.

For the 12 months ending December 2011, the total United States hypogonadism market reported sales in excess of $1.6 billion having grown 24% over the previous 12 month period. The current United States competitive landscape for testosterone preparations offers topical products, in both gel and patch presentations, short-acting injectables as well as a buccal patch. In terms of market share, topical gels represent over 88% of the total sales volume; the short-acting injectables and topical patch products each represent approximately 6% of the sales volume.

CompleoTRT™ (formerly TBS-1)

Trimel is developing CompleoTRT™, an intranasal gel formulation of testosterone.  CompleoTRT™ is designed to provide men with Low T with superior safety and enhanced convenience over currently available treatment options.  CompleoTRT™ is applied to the interior lateral wall of the nasal cavity, where it is fully absorbed into the nasal mucosa within 10-15 minutes.  It is expected that, as a result of the targeted delivery to the nasal mucosa using the unit dose applicator, CompleoTRT™ should avoid skin-to-skin transference to family members that has been the subject of an FDA boxed warning for existing topical gel preparations.

Current topical testosterone products became subject to a FDA boxed warning in May 2009, after the agency received reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).  The ages of these children ranged from nine months to five years.  Within the documented cases that the FDA had conducted full reviews, adverse events included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age and aggressive behaviour.  When using CompleoTRT™, enhanced patient convenience may be derived from the ease of application, the lack of any mess or odor from the gel, as well as the convenient dosing via the intranasal applicator.

CompleoTRT™ has concluded a multi-center multi-staged Phase II Program.  In the trials, CompleoTRT™ was dose to more than 100 patients over several weeks of treatment representing over 3,500 total doses.  This series of studies provided support that CompleoTRT™ is safe and effective for the treatment of men with Low T.  The Phase II trials met the established end point requirements of the FDA.

CompleoTRT™ entered Phase III clinical trials in September 2011.