Acrux Limited announced over 50% enrolment completion in its international phase III clinical trial of Testosterone MD-Lotion(R).  A report on the results is expected by the end of 2009.

One-hundred and fifty hypogonadal men from 27 sites in the USA, the UK, Sweden, France, Germany and Australia will actively participate in the open-label trial whose primary objective is to demonstrate that Testosterone MD-Lotion(R) restores average blood levels of testosterone into the normal range.

The trial consists of 4 months of Testosterone MD-Lotion(R) use, during which blood samples are analyzed for blood testosterone levels. Upon completion of the 4 month trial period, the subjects continue treatment for 2 months to monitor skin safety with 6 months’ continuous treatment. The first US subjects have finalized the main trial treatment period. Enrolment for the trial is expected to be completed by the end of June 2009.

Meanwhile, the transfer and scale-up of the manufacturing process for commerical supply to Orion are on track and Acrux plans to file marketing applications to regulatory authorities in the fourth quarter of 2009 as well as begin the search for marketing partners.

Acrux is an Australian drug delivery company which has developed three transdermal delivery technologies, ACROSS(R) (INSKIN(R) for cosmeceutical applications), MDTS(R) and Patchless Patch(R), with applications for management of hormonal deficiencies, central nervous system disorders, contraception and dermotological conditions.

Source: Acrux Limited