September 29, 2009
Phase 3 study of Axiron for the treatment of hypogonadismAcrux 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.
For more information visit www.acrux.com.au.