The NDA submission follows a pre-NDA meeting with the FDA and the recently announced results from the phase 3 trial of Axiron. The trial demonstrated that after four 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 with the FDA.
In addition, after only two weeks of treatment, it was found that 76% of subjects had average blood levels of testosterone within the normal range. Analysis of mood, sexual desire, sexual activity and sexual performance before and after four months of treatment showed improvement from baseline across all measures.
Richard Treagus, chief executive officer of Acrux, said: “The NDA filing is a major milestone for Axiron and for Acrux. We are now one step closer to making this novel treatment available to men living with the effects of low testosterone. The process of selecting a marketing partner for Axiron is proceeding as planned.”
Axiron is a faster-drying and pleasant smelling solution that is applied discreetly to the armpits once daily, using an ergonomic ‘no-touch’ applicator designed in Australia.