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|Molecular Formula:||C20H21F3N4O||Molecular Weight:||390.40|
|Grade:||Pharmaceutical Grade||Appearance:||White Powder|
Flibanserin Women Sex hormone white powder CAS NO 167933-07-5
Alias:3 - [2 - (4 - (4 - (3 methyl) phenyl] piperazine - 1 - base] ethyl] - 1 h - benzimidazole - 2 - ketone
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 to one over placebo from a starting point of about two to three.
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).
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.
Women's overall feeling of improvement was small to none.The overall quality of the evidence was low.
Addyi (flibanserin) is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women.
Addyi (flibanserin) 100 mg tablets, developed by Sprout Pharmaceuticals, was FDA-approved on August 18, 2015 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Flibanserin is the first approved medication for HSDD, and is classified as a multifunctional serotonin agonist antagonist (MSAA).
According to the FDA, HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.
Flibanserin has been dubbed the “Female ” and “the little pink pill”; however compared to , flibanserin has a distinctly different mechanism.
The proposed mechanism of action of flibanserin involves regulation of several brain chemicals that may affect sexual desire, although the exact mechanism is not known. Flibanserin is a post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist, as noted in FDA briefing documents, and has action in the central nervous system. The manufacturer states that flibanserin corrects an imbalance of dopamine and norepinephrine (both responsible for sexual excitement), while decreasing levels of serotonin (responsible for sexual satiety/inhibition). Flibanserin is not a hormonal drug and does not affect blood flow like the class of drugs approved for men with erectile dysfunction.
Proponents of the drug emphasize the significant unmet need of a libido-enhancing drug for women. The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance.
Addyi is taken once daily, at bedtime, to help decrease the risk of fainting, sleepiness and sedation. Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.
|Appearance||white crystals or crystalline powder, has a faint, characteristic odor and bitter taste|
|Solubility||freely soluble in water and 95%ethanol, sparingly soluble in acetic anhydride and practically insoluble in diethyl ether|
|Identification||red to dark purple color appears|
|light red precipitate formed with reinecke salt TS|
|UV spectrum meet the reference|
|solution (1%) responds to the qualitative test for chloride|
|Melting point||139-143 celcius degree|
|Clarity and color of solution||clear and colorless|
|Heavy metals||10ppm max|
|Organic acid(0.1M NaOH)||0.54ml max|
|Loss on drying||0.5% max|
|Residue on ignition||0.1%max|
|Residual organic Solvents (GC)||Xylol 0.217%max|
|Related substances(HPLC)||Total impurity 1.5%max|
|Free P-chloro phenoxy acetic 0.5%max|
|Count of bacteria||bacillus 1000/1g max|
|Mildew 100/1g max|
|Microzyme 100/1g max|
|Assay(C12H16CINO3.HCl, on dry basis)||98%min|