BioSante Pharmaceuticals has completed its two pivotal LibiGel efficacy trials.
LibiGel is used for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder in menopausal women, for which there is no US Food and Drug Administration-approved product.
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LibiGel is absorbed quickly through the skin, delivering testosterone to the bloodstream evenly over time.
BioSante clinical development vice president Joanne Zborowski said there were over 1,100 subjects enrolled in the two efficacy trials, and that the company looks forward to analysing the data and announcing the results later this year.
In a Phase II trial, LibiGel increased the number of satisfying sexual events in surgically menopausal women suffering from hypoactive sexual desire disorder by 238% versus baseline, and showed a safety profile similar to that observed in the placebo group.
The randomised double-blind placebo-controlled multi-centre cardiovascular events and breast cancer Phase III LibiGel safety study enrolled around 3,656 women and primary analysis of safety data is targeted for the third quarter of 2012.
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By GlobalDataUpon completion of the safety study and efficacy trials, BioSante intends to submit a new drug application to the US Food and Drug Administration.
The submission is scheduled for the fourth quarter of 2012.
