Female Libido Enhancer Flibanserin CAS: 167933-07-5 Pharmaceutical Drug
Description:
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.
Basic Information:
Chemical name: Flibanserin
MF; C20H21F3N4O
MW: 390.4
CAS: 167933-07-5
Appearance: White powder
Usage: Female enhancement
COA:
| Product name | Flibanserin | ||
| CAS No. | 167933-07-5 | Outer Packing | 1Kg |
| Production date | 2016.03.07 | Shelf life | 2018.03.06 |
| Standard adopted | In-house quality standard | ||
| Items of analysis | Specification | Results | |
| Appearance | White to off-white powder | White powder | |
| Identification | IR,NMR | Complies | |
| Loss on drying | Less than 0.5% | 0.13% | |
| Heavy metals | Less than10ppm | Conforms | |
| Other impurity | Any other impurity: Less than 0.3% | 0.081% | |
| Other impurity | Total of all other impurity: Less than 1.0% | 0.14% | |
| Assay (HPLC) | More than 99.0% | 99.86% | |
| Residual solvents(GC) | Ethanol: Less than 500ppm | 42ppm | |
| Residual solvents(GC) | Ethyl acetate: Less than 500ppm | ND | |
| Conclusion | Qualified | ||
Medical uses:
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.
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