Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder

Abstract

In naturally postmenopausal women with HSDD, flibanserin, compared with placebo, has been associated with improvement in sexual desire, improvement in the number of SSEs, and reduced distress associated with low sexual desire, and is well tolerated.

Flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women

“…Other Phase III studies provided supportive data on efficacy (i.e., 511.130, also known as SNOWDROP, in postmenopausal women), as well as information on the long-term safety of flibanserin, possible withdrawal effects, and the tolerability of flibanserin when taken with selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs) [14,18]. …”

Flibanserin: First Global Approval

“…With the exception of vomiting, these AEs were the most frequent AEs considered to be related to flibanserin; no serious AEs were considered related to the drug [32]. Likewise, no safety concerns were raised in the ROSE trial [31], with the most common AEs being somnolence ( The tolerability profile of flibanserin in postmenopausal women with HSDD was consistent with that in premenopausal women, according to data from the 24-week phase III SNOWDROP study [33]. Most AEs in the flibanserin and placebo groups were mild or moderate, the most common of which were dizziness (9.9 vs. 3.1 %), somnolence (8.8 vs. 1.5 %), nausea (7.5 vs. 3.5 %) and headache (6.0 vs. 4.8 %); no serious AEs were considered to be drug related.…”

“…In a 24-week phase III trial known as SNOWDROP (NCT00996372), flibanserin 100 mg once daily at bedtime significantly (p B 0.004) increased SSE number (mean change from baseline of 1.0 vs. 0.6) and sexual desire (mean change from baseline in FSFI desire domain score of 0.7 vs. 0.4) relative to placebo in naturally postmenopausal women with HSDD [33]. In addition to these coprimary endpoints, flibanserin significantly (p \ 0.01) improved overall sexual function (FSFI total score), sexual distress (FSDS-R total score) and distress related to low sexual desire (FSDS-R item 13 score).…”

“…In addition to these coprimary endpoints, flibanserin significantly (p \ 0.01) improved overall sexual function (FSFI total score), sexual distress (FSDS-R total score) and distress related to low sexual desire (FSDS-R item 13 score). A total of 949 women were randomized in this double-blind study [33].…”

Flibanserin: a serendipitous story

“…The drug has also been studied in post-menopausal women and as shown improvement in sexual desire and it increase in the number of sexually satisfying events. 14 It is important that a prescriber ensures that a patient being prescribed flibanserin does not have sexual desire disorder arising out of poor relationship, drug toxicity, other medical or psychiatric illness as the drug is very unlikely to demonstrate benefit in these settings.…”