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FDA Approves Sexual Desire Disorder Drug

Flibanserin (Addyi) approved to treat premenopausal women

Indications: Flibanserin (Addyi) is approved for the 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.

Dosing: Recommended dosage is 100 mg taken once daily at bedtime. Discontinue treatment after 8 weeks if no improvement.

Pharmacokinetics: Flibanserin showed dose-proportional pharmacokinetics for Cmax after single oral doses of 100 mg to 250 mg (the recommended and 2.5 times the recommended dosage, respectively) in healthy female subjects. Steady state was achieved after 3 days of dosing. The extent of exposure with once-daily dosing of 100 mg of flibanserin was increased 1.4-fold as compared to a single dose.

Effectiveness: In clinical trials, treatment with flibanserin increased the number of satisfying sexual events by 0.5 to 1 additional event per month over placebo, increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo.

Side Effects/Risks: The most common adverse reactions are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.  

More Information: Addyi is not indicated for HSDD due to a co-existing medical or psychiatric condition, problems within a relationship, or the effects of a medication or other drug substance.

Source: Highlights of Prescribing Information: Addyi. U.S. Food & Drug Administration website. www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526Orig1s000lbl.pdf.  Revised August 2015. Accessed August 19, 2015.

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