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Home » ACRUX TO BEGIN TRIAL OF TESTOSTERONE LOTION
ACRUX TO BEGIN TRIAL OF TESTOSTERONE LOTION
September 20, 2006
Acrux announced it will soon begin a Phase II trial in the U.S. following the recent FDA acceptance of an investigational new drug application for Testosterone MD-Lotion.
The aim of the trial, which will enroll 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 trial are expected to be available in the second quarter of 2007. If successful, a Phase III registration trial will then take place before a marketing application is submitted to the FDA in the second half of 2008.
The trial is a randomized, open-label, two-way crossover study. The primary endpoint is measurement of the level of testosterone in the blood and other pharmacokinetic parameters after daily application to the armpit of two different doses of Testosterone MD-Lotion for seven days.
The Acrux product will apply a precise dose of quick-drying lotion to the armpit once daily, via a no-touch applicator. The leading gels are applied by hand to larger areas of the torso and take longer to dry, and patients are advised to wear protective clothing after application to reduce the risk of transferring testosterone to others. Acrux's lotion would form part of a normal grooming routine and it could be discreetly applied in public, much like a deodorant.
KEYWORDS Drug Pipeline Alert
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