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 (HSDD).
M2 EQUITYBITES-January 10, 2017-AMAG Pharmaceuticals partners with Palatin Technologies to develop and commercialise Rekynda for
hypoactive sexual desire disorder in women
M2 PHARMA-January 10, 2017-AMAG Pharmaceuticals partners with Palatin Technologies to develop and commercialise Rekynda for
hypoactive sexual desire disorder in women
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.
