FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder

Flibanserin: a serendipitous story

“…The development of this molecule was fraught with several hurdles and has certainly opened a Pandora's box in female sexual disorders. 6 We seek to review the literature on flibanserin bringing to focus the mechanism of action, efficacy, safety and regulatory history of this molecule.…”

Flibanserin Approval: Facts or Feelings?

“…In what might be an unprecedented action, Hylton Joffe, in his role as director of the Division of Bone Reproductive and Urologic Products at the FDA, and his colleagues in this division, defended their decision of flibanserin as having a positive risk-benefit ratio 1 . However, their commentary reinforced and perpetuated some of the agency's concerns (their feelings) surrounding the flibanserin approval.…”

“…The Executive Committee of ISSWSH applauds the publication of the article by Joffe et al 1 in the New England Journal of Medicine that summarizes the historic development program of flibanserin and their first-ever women's sexual health approval of a safe and effective drug for the treatment of HSDD.…”

“…Unfortunately, Joffe et al mischaracterized the benefits of flibanserin as “small” (Table 1 in Joffe et al 1 ) and overemphasized the risks of flibanserin. We believe that emphasizing the facts would be helpful for those health care practitioners who are uncertain as to benefit of flibanserin for their premenopausal patients with bothersome low sexual interest 1 …”

“…With HSDD, the clinical benefits get “watered down” by non-responders, placebo response, and high levels of baseline “duty” sex 3 . Responder analyses (conspicuously absent 1 ) clarify the actual benefits of this medical therapy. Responders, defined by self-report on the Patient Global Impression of Improvement, show a return to near normal premenopausal frequencies of sexual activity 4 in 8 weeks, despite HSDD of 4.5 years' duration (mean) in these trials.…”