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Why are there no FDA-approved treatments for female sexual dysfunction?

After many years of research, female sexual dysfunction (FSD) is still an unmet clinical need because no FDA-approved treatments are available for women. The bio-psychosocial model is essential to understand whether a candidate drug induces a meaningful effect over placebo on sexual symptoms with a significant impact on women’s quality of life and partnership. Vasoactive agents, hormone therapy and psychoactive drugs have been investigated. Randomized placebo-controlled trials showing efficacy and safety, however, did not convince the FDA to approve either transdermal testosterone patch in postmenopausal women or the serotoninergic agent flibanserin in premenopausal women, for the treatment of hypoactive sexual desire disorder. The process of balancing efficacy and safety of a chronic treatment for a non-life threatening condition, such as FSD, is very difficult in women of any age, but there is some hope that the gender gap in sexual medicine will soon come to an end. Insightful research centered on women’s needs and expectations and the availability of novel compounds, tested according to the new DSM-5 diagnostic criteria, will finally lead medical regulatory agencies to approve an effective and safe pharmacotherapy for FSD.