The company has completed full randomization of 75 patients into the safety portion of the CompleoTRT Phase III trial.
This cohort of 75 patients will be maintained on their CompleoTRT regimen beyond the duration of the 90-day efficacy component of the study in order to confirm the safety profile.
"This is yet another important milestone achieved for our lead product. Moreover, it is doubly important as we achieved this milestone within the time frame to which we originally committed." said Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel. "With the safety cohort now randomized into the study Trimel is one step closer to filing the NDA for CompleoTRT."
CompleoTRT is designed to represent a significant advancement in the treatment of male hypogonadism, or low testosterone - commonly known as "Low T". CompleoTRT's unique delivery technology is designed to provide patients with the therapeutic effect of supplementing testosterone levels while doing so with a small amount of drug in the form of a bio-adhesive intranasal gel.
CompleoTRT's intranasal no-touch delivery system is designed to avoid the risk of accidental transfer (secondary transference) of testosterone to spouses or other family members, thus offering unique patient benefits and improved safety as compared to other currently marketed products indicated to treat "Low T". Moreover, CompleoTRT is designed to avoid the negative effects from first-pass metabolism on the product, liver, or both.
Since Trimel took over development in May 2009, CompleoTRT has been optimized to meet FDA regulatory requirements, including the development of a no-touch applicator device that is designed to ensure that CompleoTRT is dosed accurately and discretely. Trimel's research program to date has demonstrated that CompleoTRT is safe and effective, with over 4000 drug exposures studied thus far in the United States.
About Hypogonadism ("Low T")
Subject to FDA approval, Trimel's lead product candidate, CompleoTRT, would be indicated for the treatment of male hypogonadism or low testosterone - commonly known as "Low T". Hypogonadism is a biochemical syndrome characterized by a deficiency in serum testosterone levels that can be either acquired or inherited, and seriously affects the quality of life for those affected with the syndrome. Low testosterone is estimated to affect 13 million men in the United States, of which an estimated 90% go untreated. According to IMS Health, sales of marketed treatments for low testosterone in North America exceeded $1 billion annually in 2010.