Ardana's testosterone cream on track for Ph III

Edinburgh, Scotland-based drugmaker Ardana has had a pre-Investigational New Drug meeting with the US Food and Drug Administration to discuss the development of its novel cream for testosterone replacement in male hypogonadism.

The firm, which specializes in reproductive health, agreed with the agency on the next steps in the product's development, which should allow it to meet its scheduled launch of end-2007. Ardana is planning to submit an IND to the FDA within a few months and expects to commence a Phase III pivotal registration trial by first-half 2006.

The Scottish drugmaker has also completed enrolement in a Phase II dose-finding study and a Phase II dose-titration trial in support of the registration of the testosterone cream that is also on track to commence in the first half.