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What's Flibanserin?

Edit: Shenzhen OK Biotech Technology Co., Ltd. (SZOB)    Date: Aug 20, 2015

What's Flibanserin?

 

Flibanserin

(INN, USAN) (trade name Addyi, former proposed trade names Ectris, Girosa, and former developmental code name BIMT-17) is a drug(Flibanserin,167933-07-5,Flibanserin 167933-07-5) approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD).[1][2]
Development by Boehringer Ingelheim was halted in October 2010 following a negative evaluation by the U.S. Food and Drug Administration.[3] The rights to the drug were then transferred to Sprout Pharmaceuticals, which achieved approval of the drug by the United States Food and Drug Administration in August 2015.
HSDD was recognized as a distinct sexual function disorder for more than 30 years, but was removed from the Diagnostic and Statistical Manual of Mental Disorders in 2013, and replaced with a new diagnosis called female sexual interest/arousal disorder (FSIAD).[4][5]
Contents  [hide]
1 Effectiveness
2 Mechanism of action
3 Society and culture
3.1 Approval process and advocacy
3.2 Even the Score
4 See also
5 References
6 External links
Effectiveness[edit]
Some studies found that flibanserin increased sexually satisfying events, and some did not, depending on how it was measured.
The medication increases the number of satisfying sexual events per month by about one half to one over placebo from a starting point of about two to three.[6]
Trials involving more than 5,000 pre-menopausal women with generalized acquired HSDD demonstrated that:[7][8]
Although the two North American trials that used the flibanserin(Flibanserin,167933-07-5,Flibanserin 167933-07-5) 100 mg qhs dose showed a statistically significant difference between flibanserin(Flibanserin,167933-07-5,Flibanserin 167933-07-5) and the placebo for the endpoint of [satisfying sexual events], they both failed to demonstrate a statistically significant improvement on the co-primary endpoint of sexual desire. Therefore, neither study met the agreed-upon criteria for success in establishing the efficacy of flibanserin for the treatment of [Hypoactive Sexual Desire Disorder].
The women receiving flibanserin reported that the average number of times they had “satisfying sexual events” rose from 2.8 to 4.5 times a month. However, women receiving placebo reported also an increase of “satisfying sexual events” from 2.7 to 3.7 times a month. Evaluation of the overall improvement of their condition and whether the benefit was meaningful to the women, showed a significantly higher rate of a meaningful benefit in the flibanserin-treated people versus the placebo group.[9] The onset of the flibanserin effect was seen from the first timepoint measured after 4 weeks of treatment and maintained throughout the treatment period.[10] The overall incidence of adverse events among women taking flibanserin(Flibanserin,167933-07-5,Flibanserin 167933-07-5) was low, the majority of adverse events being mild to moderate and resolved during the treatment. The most commonly reported adverse events included dizziness, nausea, fatigue, somnolence, and insomnia.[8]

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