Australian company, Acrux, today announced positive results from a Phase III trial evaluating the safety and efficacy of AXIRON™ in 155 men with testosterone deficiency (hypogonadism), across 26 sites in six countries.
AXIRON™ is applied to the underarm using a unique “no-touch” applicator. Upon approval, AXIRON™ would be the first and only pharmaceutical product applied to the armpit - in much the same way as an antiperspirant. As well as existing patents that protect AXIRON™ to 2017, Acrux has a new patent that, when granted, will extend protection of this novel, class-leading feature until 2026.
Phase III trial results
The trial met its primary endpoint by demonstrating that after four months of treatment with AXIRON™, 84 percent of subjects achieved average blood levels of testosterone within the normal range, exceeding the requirement of 75 percent that was agreed upon by the U.S. Food and Drug Administration (FDA).
After only two weeks of treatment, it was found that 76 percent 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, and the trial demonstrated that the optimum dose for 75 percent of subjects was 60mg testosterone per day, equivalent to one single application of AXIRON™ to each armpit.
Subjects were permitted to use an underarm deodorant or antiperspirant during the trial. More than half of the men continued to apply an underarm deodorant or antiperspirant as part of their daily routine, and an analysis of these subgroups showed that this had no impact on the efficacy of AXIRON™ treatment.
Analysis of mood, sexual desire, sexual activity and sexual performance before and after four months of treatment showed significant improvement from baseline across all measures.
There were no serious adverse events related to treatment with AXIRON™ and no adverse trends were identified with the biochemical safety measures, including prostate specific antigen, haematocrit, and the ratio of dihydrotestosterone to testosterone.
Fifty-two men continued treatment for an additional two months specifically to monitor skin safety with six months of continuous use. Eight subjects reported some form of transient application site reaction during the main treatment phase of four months; however, these reported events were all mild or moderate and resolved quickly without any intervention. No patient withdrew due to a skin reaction.
“In terms of the proportion of responders to testosterone replacement using AXIRON™, the pharmacokinetic parameters and the response from this multi-center clinical trial, the results are very exciting and precisely what we had hoped to see,” commented lead investigator Professor Christina Wang, MD, at Los Angeles Biomedical Research Institute and Professor of Medicine at David Geffen School of Medicine at UCLA. “The post-treatment changes demonstrated positive responses in sexual desire, sexual activity, mood and general well-being, underpinning the patient- reported benefits of this treatment. Patient compliance and acceptance of the unique no-touch axilla application technique was very good, as evidenced by the high completer rate,” added Professor Wang.
Earlier this month, Acrux announced it had held a pre-NDA meeting with the FDA in Washington, DC and the FDA had agreed Acrux may proceed to file a New Drug Application (NDA) in the United States, which Acrux is targeting for the end of 2009.