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Two Bio Sante execs call for an FDA-approved hypoactive sexual desire disorder treatment


A paper set to appear in next month’s issue of The Journal of Sexual Medicine by two executives from BioSante Pharmaceuticals calls for a Food and Drug Administration-approved testosterone treatment for hypoactive sexual desire disorder.


The paper, “Approved Hormonal Treatment for HSDD: An Unmet Medical Need,” by BioSante president and CEO Stephen Simes and VP clinical development Michael Snabes uses results from independent surveys indicating that 80% of physicians see a need or great need for an FDA-approved treatment for women with HSDD, and 90% of them would prescribe an approved product rather than currently available off-label therapies.


The high number of off-label prescriptions is related to an increase in the number of women with HSDD seeking treatment for distress resulting from their decrease in sexual desire, and Simes and Snabes wrote that low sexual desire is “nearly twice as high in naturally menopausal women as in pre-menopausal women (52.4% vs. 26.7%).”


BioSante is conducting two phase 3 efficacy studies and one phase 3 safety study of LibiGel (testosterone gel) and plans to submit an approval application to the FDA by mid-2011.

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