Pharmaceutical Raw Materials Sex Enhancing Drugs Flibanserin CAS 167933-07-5 Female Libido Enhancer

Description:

Flibanserin, sold under the trade name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive 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 drug developed to treat hypoactive sexual desire disorder (HSDD) in women. Women with HSDD have a chronic lack of interest in sex that cannot be explained by another medical condition. HSDD is also accompanied by feelings of distress. Sometimes, flibanserin is called the “female ,” but that term isn’t quite accurate. is a drug used to treat erectile dysfunction in men and works by improving blood flow to the penis. In other words, it mainly works on the genitals. Flibanserin is different because it works on a woman’s brain. The brain is often considered a woman’s more important sexual organ. Much of her sexual response cycle originates in her brain.

Flibanserin is the first drug to be approved for hypoactive sexual desire disorder (HSDD) in premenopausal women by the FDA in August 2015. It was originally developed as an antidepressant medication by Boehringer Ingelheim, but showed lack of efficacy in trials and was further developed as a hypoactive sexual disorder drug by Sprout Pharmaceuticals. Flibanserin's mechanism of action is attributed to its high affinity for 5-HTA1 and 5-HTA2 receptors, displaying agonist activity on 5-HTA1 and antagonist on 5-HTA2, resulting in lowering of serotonin in the brain as well as an effect on increasing norepinephrine and dopamine neurotransmitters. Flibanserin is being hailed as "s for women." The experimental drug - designed for post-menopausal women with low sex drives - has now won approval from an advisory panel for the Food and Drug Administration (FDA).

Flibanserin is an antidepressant that failed to help depression in clinical trials, but was noted to have improved sexual health outcomes. It's not uncommon for a drug to be developed for one purpose, then approved for another. Sildenafill was originally developed to lower blood pressure, but failed those trials. The benefit of both of these drugs was discovered by accident. However, flibanserin has now been studied for its effects on sexual health for nearly a decade. Flibanserin doesn't have any interactions with hormonal medications, Thorp says. It does seem to interact with the original libido helper, though: some panelists recommended a warning against drinking alcohol while taking it, Reuters reported. (Interested in natural alternatives to hormone replacement therapy? The Natural Menopause Solution has everything you need to tame symptoms and trigger rapid, healthy weight loss in menopausal women. Flibanserin (INN, USAN), sold under the trade name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD).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. Flibanserin ( Addyi ) 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.

COA:

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.

Flibanserin works on three important brain chemicals: dopamine, norepinephrine, and serotonin. These chemicals are neurotransmitters. They are responsible for sending signals between the brain and other parts of the body through the nervous system. Dopamine and norepinephrine are involved with sexual excitement. However, serotonin contributes to sexual inhibition and may dampen sex drive. It is thought that if these chemicals are out of balance – if dopamine and norepinephrine levels are too low and/or serotonin levels are too high – a woman might feel less sexual desire. Flibanserin works by raising levels of dopamine and norepinephrine while lowering levels of serotonin. In this way, chemicals that help promote sexual desire are increased and one that can suppress desire is decreased. Flibanserin is a pill to be taken once a day at bedtime.

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. A new drug designed to boost sexual desire in women is controversial for some and eagerly awaited by others, but it's hit a potentially serious snag. The drug didn't boost women's desire any more than a placebo in two clinical trials. The Food and Drug Administration posted the clinical trial results on its website today in advance of a committee meeting on Friday, when a panel of experts will vote whether or not to recommend approval of the drug called flibanserin. (The FDA usually follows the recommendations of its expert panels. ) Although there was a slight increase in the number of sexually satisfying events flibanserin users had each month, the FDA staff who reviewed the results said the so-called response rate isn't "particularly compelling. "
It's called the "little pink pill, " a tiny tablet that could have a huge impact on treating female sexual dysfunction. If it's approved, it would become the first drug of its kind on the market.

Dosage:

(1) Recommended dosage is 100 mg taken once daily at bedtime.
(2) Taking it at night reduces the risk of sleepiness, low blood pressure, and fainting during waking hours.
(3) If your symptoms do not improve after 8 weeks of treatment, stop treatment and call your doctor.
(4) If a dose is missed at bedtime, take the next dose at bedtime the following day. Do not take a double
dose to make up for a missed one.

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