Xiamen Sheng Lang SaiChuang Biological Technology Co., Ltd

CAS 167933-07-5 Flibanserin

Product Name:Flibanserin

CAS NO.:167933-07-5

Molecular Formula:C20H21F3N4O

Molecular Weight:390.40

Purity:99%

Grade:Pharmaceutical Grade

Appearance:White powder

Grade:Pharmaceutical Grade

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.

Flibanserin is used for hypoactive sexual desire disorder among women. Those receiving flibanserin report that the average number of times they had “satisfying sexual events” rose from 2.8 to 4.5 times a month. However, women receiving placebo reported also an increase of “satisfying sexual events” from 2.7 to 3.7 times a month. Evaluation of the overall improvement of their condition and whether the benefit was meaningful to the women, showed a significantly higher rate of a meaningful benefit in the flibanserin-treated people versus the placebo group.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 a statistically significant 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 a statistically significant increase relative to women treated with a placebo. These two trials also measured sexual desire using the Female Sexual Function index (FSFI) as a secondary endpoint, and a statistically significant 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.

Dosage:

100 mg orally once per day at bedtime

Duration of therapy: This drug should be discontinued after 8 weeks if the patient does not report an improvement in symptoms.

Comments: This drug is not indicated to enhance sexual performance, and is not indicated for treatment in postmenopausal women or in men.

Use: Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as 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.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Contraindicated in patients with hepatic impairment.

Dose Adjustments

If Initiating this Drug Following Use of Moderate or Strong CYP450 3A4 Inhibitor:

-Start this drug 2 weeks after the last dose of the CYP450 3A4 inhibitor.

If Initiating a Moderate or Strong CYP450 3A4 Inhibitor Following Use of This Drug:

-Start the CYP450 3A4 inhibitor 2 days after the last dose of this drug.

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Addyi. It includes elements to assure safe use and an implementation system. 

US BOXED WARNING:

HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS:

-Contraindicated with Alcohol: Concomitant use of this drug with alcohol increases the risk of severe hypotension and syncope. Patients should be counseled about the importance of abstaining from alcohol, and their current and past drinking behavior as well as other pertinent social and medical history should be assessed before this drug is prescribed.

-Contraindicated with Strong or Moderate CYP450 3A4 Inhibitors: Concomitant use of this drug with strong or moderate CYP450 3A4 inhibitors increases the concentration of this drug, which can result in severe hypotension and syncope.

-Contraindicated in Patients with Hepatic Impairment: The concentration of this drug is increased when used in patients with hepatic impairment, which can result in severe hypotension and syncope.

Safety and efficacy have not been established in patients younger than 18 years.

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