Canada’s Trimel Pharmaceuticals (TSX:TRL) has completed a preliminary review of early data from its ongoing Phase III clinical trial with its hypogonadism therapy CompleoTRT, showing that 79.9% of patients treated with the product achieved an average serum testosterone (AST) level within the normal range. These results exceed the threshold required by the US Food and Drug Administration to confirm the efficacy of a testosterone replacement product.
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 is in development for the treatment of male hypogonadism, a condition that is estimated to affect more than 13 million men in the USA, with only 10% currently receiving treatment according to the latest epidemiological data.
According to IMS Health, revenues of marketed treatments for low testosterone in North America grew 24% in 2011 versus 2010 to now exceed $1.6 billion in annual sales volume.
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