CAS Registry number: 167933-07-5
Molecular Formula: C 20 H 21 F 3 N 4 O
Density: 1.292 g/cm 3
Flibanserin hydrochloride powder, is a medication approved for the treatment of pre-menopausal women
withhypoactive sexual desire disorder (HSDD). The medication increases
the number of satisfying sexual events per month by about one half over
placebo from a starting point of about two to three. The certainty of
the estimate is low. The side effects of dizziness, sleepiness, and
nausea occur about three to four times more often.
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 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 an 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 an 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.
