FDA approves topical solution for low testosterone

December 16, 2010

The FDA has approved testosterone topical solution CIII (Axiron) for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone.

The FDA has approved testosterone topical solution CIII (Axiron) for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone.

The treatment is the first testosterone topical solution approved for application via an armpit applicator, according to manufacturers Eli Lilly and Co. and Acrux.

A phase III multicenter, open-label, 120-day clinical study demonstrated that 84% of men who completed the study achieved average serum testosterone concentration within the normal range of 300 to 1,050 ng/dL. Additionally, after 120 days of treatment, 75% of responding patients finished the study on the recommended starting dose of 60 mg.

The most common adverse reactions (incidence greater than 4%) in the study were skin application site reactions, increased red blood cell count, headache, diarrhea, vomiting, and an increase in PSA.