Phase 3 study of Axiron for the treatment of hypogonadism

Acrux announced positive results from its Phase 3 trial of Axiron (testosterone topical solution 2%) for the treatment of testosterone deficiency (hypogonadism).  This multi-national study evaluated the safety and efficacy of Axiron in 155 men with testosterone deficiency (hypogonadism). Axiron is applied to the underarm using a “no-touch” applicator, in much the same way as an antiperspirant.  This trial met its primary endpoint by demonstrating that after 4 months of treatment with Axiron, 84% of subjects achieved average blood levels of testosterone within the normal range, exceeding the requirement of 75% that was agreed upon by the FDA. After only two weeks of treatment, 76% of subjects had average blood levels of testosterone within the normal range. The average testosterone level for the responder group after 120 days treatment with Axiron was 504ng/dl (the normal range being 300-1,050ng/dl). The average baseline testosterone level in subjects prior to treatment was 190ng/dl. Four different dose levels of Axiron were tested; the trial demonstrated that the optimum dose for 75% of subjects was 60mg testosterone per day, equivalent to one single application of Axiron to each armpit. Acrux plans to file the NDA for Axiron at the end of 2009.  

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