FDA approval of flibanserin--treating hypoactive sexual desire disorder
Prevalence of low sexual desire and hypoactive sexual desire disorder
in a nationally representative sample of US women.
It also reviews key players involved in the therapeutic development for Female Hypoactive Sexual Desire Disorder
and special features on late-stage and discontinued projects.
At a joint meeting of two FDA advisory panels on June 4, members of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18-6 that the overall benefit-risk profile of flibanserin supported approval for treating hypoactive sexual desire disorder
(HSDD) in premenopausal women, provided that certain risk management options beyond labeling were implemented.
A randomized, double-blind, placebo controlled study of the efficacy and safety of bupropion lot treating hypoactive sexual desire disorder
in ovulating women, BJU Int.
The FDA's Reproductive Health Drugs Advisory Committee voted 10-1 that the studies presented by Boehringer Ingelheim Pharmaceuticals did not provide enough evidence that flibanserin, a centrally acting drug, was an effective treatment for hypoactive sexual desire disorder
(HSDD), a persistent or recurrent deficiency or absence of desire for sexual activity.
Hypoactive sexual desire disorder
is the most common sexual dysfunction among couples seeking sex therapy (Davies, Katz, & Jackson, 1999; Donahey & Carroll, 1993; Hurlbert, Apt, & Hurlbert, 1995; MacPhee, Johnson, & Van Der Veer, 1995).
LibiGel is a testosterone gel in Phase III development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder
M2 EQUITYBITES-January 10, 2017-AMAG Pharmaceuticals partners with Palatin Technologies to develop and commercialise Rekynda for hypoactive sexual desire disorder
M2 PHARMA-January 10, 2017-AMAG Pharmaceuticals partners with Palatin Technologies to develop and commercialise Rekynda for hypoactive sexual desire disorder
Thus, the treatment focus for hypoactive sexual desire disorder
(HSDD) shifted to testosterone.
FDA advisory panelists voting in favor of flibanserin for hypoactive sexual desire disorder
in premenopausal women might not have done so without the option of recommending physician certification as a condition of approval.