Acrux has announced the results of an 8-month clinical trial conducted in the United States, demonstrating that its Testosterone MD-Lotion™ applied to the armpit of men with low testosterone was able to effectively and safely restore testosterone levels into the normal range, with no adverse side effects.
The completion of the phase 2 trial, carried out across nine different centers in the US, now paves the way for the phase 3 trial -- the final step needed prior to Acrux seeking marketing approval from the US Food and Drug Administration (FDA) and other regulatory bodies in Europe and Australia.
Acrux is on track to commence the phase 3 trial in the first half of 2008. Subject to successful completion of phase 3, the company will then submit a marketing application to the FDA in the second half of 2009 with product launch in the US market and beyond expected in late 2010.
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