Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

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.

This Week's Must Reads

Do Vitamin D Supplements Prevent Cancer, CVD?, N Engl J Med; 2019 Jan 3; Manson, Cook, et al

Nonadherence to Cancer Screenings & Related Mortality, JAMA Intern Med; ePub 2018 Dec 28; Pierre-Victor, et al

Alcohol Consumption After Development of HF, JAMA Netw Open; ePub 2018 Dec 28; Sadhu, et al

Opioid-Involved Overdose Deaths in the US, MMWR; 2019 Jan 4; Scholl, Seth, et al

Assessing the Diet Quality of US Children, Am J Clin Nutrit; ePub 2018 Dec 29; Thomson, et al

Must Reads in Women's Health

Hypertensive Diseases of Pregnancy & Risk of HF, Mayo Clin Proc; ePub 2018 Dec 19; Nizamuddin, et al

Recent Childbirth a Risk Factor for Breast Cancer, Ann Intern Med; ePub 2018 Dec 11; Nichols, et al

BMI & Risk of Postpregnancy T2D in Women with HDP , Diabetes Care; ePub 2018 Nov 19; Timpka, et al

Traumatic Exposures & Health Issues in Older Women, JAMA Intern Med; ePub 2018 Nov 19; Gibson, et al

Paternal Age and Perinatal Outcomes in the US, BMJ; ePub 2018 Oct 31; Khandwala, et al