Flibanserin HCL (INN, USAN) (developmental code name BIMT-17; proposed trade names Girosa and Addyi) is a drug that is being studied as a non-hormonal treatment for pre-menopausal women with hypoactive sexual desire disorder (HSDD).
Certification of Analysis
Test Items | Test Specifications | Test Results |
Appearance | An off-white to white powder | Complied |
Identification | Meet the requirements | Positive |
Loss on Drying | ≤0.50% | 0.13% |
Heavy Metals | ≤20PPM | <20PPM |
Purity (by HPLC) | ≥99.0% | 99.2% |
Conclusion: | Conform to standard |
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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.
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