Acrux gets results in libido trial

Acrux (ASX: ACR) has reported positive results from the Phase IIb trial of its testosterone MDTS spray in pre-menopausal women with low libido.

As a result of the completion of the Phase IIb study, Acrux's commercialisation partner Vivus, which has a licence for the US market, will pay a milestone payment of US$375,000 to Acrux. Vivus will also focus on getting a Phase III trial up and running in the US following discussions with the FDA on the trial design, and hopes to commence the trial this year.

"We are very pleased -- it's the first time anyone has done an FDA-approved study [of testosterone] in premenopausal women," said CEO Igor Gonda.

Previous studies evaluating the use of testosterone to restore female libido have been restricted to post-menopausal women, or surgically menopausal women.

"Most of the research done to date has involved women who have already passed through the menopause, but lots of younger women have problems which are not solved with counselling or lifestyle changes. A proportion of such younger women have low blood testosterone levels," said Monash University's Professor of Women's Health Susan Davis, principal investigator of the trial.

"We have shown in this study that by restoring testosterone hormone levels back to normal, women's sexual lives are restored as well, to a significant extent."

Three doses were tested in the randomised double-blinded placebo-controlled study, which was carried out at six sites across Australia on 261 premenopausal women with low libido and low serum testosterone levels. The trial looked at the number of satisfactory sexual events in the women using the spray over a 16 week period, with the primary endpoint the number of satisfactory sexual events measured during the four week period ending at week 16.

A statistically significant increase was observed in the cohort taking the second-highest dose of testosterone, more than doubling from the baseline. There were no adverse effects, with the most common side effect being a mild increase in hair growth. The results will be presented in full at a major conference in the US later this year.

Acrux has already licensed the rights for the Australian and New Zealand market to CSL, and is looking for partners for other key markets including Europe.

Last year, the FDA declined to approve competitor Proctor & Gamble's testosterone patch Intrinsa, which had been tested in surgically menopausal women, citing in part the need for further safety assessment on long term use. The delay has given Acrux and Vivus the chance to catch up and potentially capture a larger market share.