Acrux to start US trial of testosterone lotion

Acrux, a Melbourne, Australia-based drug-delivery company says that it will start a Phase II clinical trial in the USA following the recent acceptance of an Investigational New Drug Application for Testosterone MD-Lotion by the US Food and Drug Administration.

The aim of the trial, in 40 men with testosterone deficiency, is to demonstrate that once-daily use of the quick-drying lotion maintains testosterone levels within the normal range. Results of the study are expected to be available in the second quarter of 2007. If successful, a Phase III registration trial approved by the FDA will then be required before a US marketing application is submitted to the agency in the second half of 2008.