Acrux will start partnering discussions and projects filing an NDA by year-end.
Australian firm Acrux reports positive results from an international Phase III trial evaluating its topically applied testosterone replacement product, Axiron™, in 155 men with hypogonadism. The company aims to start formal partnering discussions for the product during October and projects filing an NDA by the end of 2009.
The late-stage study confirmed that after four months of treatment, 84% of subjects using Axiron achieved average blood testosterone levels within the normal range. The company points out that this exceeds the 75% threshold expected by FDA. Trial data also showed that 76% of treated subjects achieved normal blood levels of testosterone after two weeks of treatment.
Axiron is applied to the underarm using a no-touch applicator. In the Phase III trial, the optimum dose for 75% of patients was 60 mg testosterone per day, equivalent to a single application of Axiron to each armpit. Acrux says use of underarm deodorant in addition to Axiron had no adverse effects on its efficacy.