BioSante's LibiGel passes safety hurdle

BioSante is a step closer to being the first drugmaker with a treatment for female sexual dysfunction. The company announced positive safety results from a Phase III trial of LibiGel, a testosterone gel that's applied directly to the skin. Of the 2,869 enrolled in the trial, 17 experienced cardiovascular events while eight incidents of breast cancer were reported. A independent data monitoring committee (DMC) determined the events were infrequent enough for testing to continue. Up to 4,000 women could be enrolled in the trial.

"Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects will be complete," said BioSante senior vice president of medical affairs Michael Snabes. "The protocol allows up to 4,000 women to be enrolled, however, the DMC may recommend completion of enrollment at any time between the current enrollment and the 4,000 women maximum."

Since Viagra's approval in 1998, dozens of potential treatments have been explored for female sexual dysfunction, a market worth as much as $2 billion annually. But no drugmaker has been able to bring a product to market. BioSante hopes to have LibiGel ready to launch by 2012 if the FDA approves its application.

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