Flibanserin
CAS 167933-07-5
Product Description:
Flibanserin is a new drug being investigated for the prevention of HSDD in woman. HSDD, is a relatively new term developed to describe Hypoactive Sexual Desire Disorder which basically means a woman whose is otherwise healthy has a lacking libido, or a lack of sexual desire. Studies show that about 10-20% of women face this problem and some say HSDD outnumbers men with sexual problems. Flibanserin is classified as a 5-HT serotonin receptor agonist and a dopamine D4 receptor partial agonist. It is a Non-Hormonal agent that in essence increases dopamine and noradrenalin while reducing Serotonin in the brain. This in return seemingly has a positive effect on a woman's sexual craving who was otherwise lacking in this area. The benefits of it being Non-Hormonal are that it will not have the problems associated with other hormonal treatments such as a negative altered mood among other issues.
Flibanserin is a novel, non-hormonal drug that has been studied in clinical trials for the treatment of HSDD in premenopausal and postmenopausal women. The application submitted to the FDA is for premenopausal women. Flibanserin is believed to work on key neurotransmitters, or chemicals, in the brain that affect sexual desire. More specifically, it is thought that flibanserin corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and decreasing serotonin (responsible for sexual inhibition). In clinical studies, flibanserin was evaluated for its ability to increase the frequency of satisfying sexual events, increase the intensity of sexual desire and decrease the associated distress women feel from its loss.
3.Product Application:
Flibanserin is used for hypoactive sexual desire disorder among women. Those receiving flibanserin report a 0.5 increase compared to placebo in the number of times they had "satisfying sexual events". In those on flibanserin it rose from 2.8 to 4.5 times a month while women receiving placebo reported also an increase of "satisfying sexual events" from 2.7 to 3.7 times a month. The onset of the flibanserin effect was seen from the first timepoint measured after 4 weeks of treatment and maintained throughout the treatment period.
The effectiveness of flibanserin was evaluated in three phase 3 clinical trials. Each of the three trials had two co-primary endpoints, one for satisfying sexual events (SSEs) and the other for sexual desire. Each of the 3 trials also had a secondary endpoint that measured distress related to sexual desire. All three trials showed that flibanserin produced a increase in the number of SSEs and reduced distress related to sexual desire. The first two trials used an electronic diary to measure sexual desire, and did not find an increase. These two trials also measured sexual desire using the Female Sexual Function index (FSFI) as a secondary endpoint, and a increase was observed using this latter measure. The FSFI was used as the co-primary endpoint for sexual desire in the third trial, and again showed a statistically significant increase.
