Woman in black and white with pink lips

Help her rediscover her sexual desire

Addyi is the first and only FDA-approved treatment for acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. Symptoms of HSDD include chronically low sexual desire, which your patients may call low libido, and associated personal distress.

Decreased Sexual Desire Screener (DSDS)

The Decreased Sexual Desire Screener (DSDS) - a short, validated tool - can assist in diagnosing Hypoactive Sexual Desire Disorder.1

Addyi Clinical Results

Addyi Bottle and Pill

Addyi has been shown to increase sexual desire and satisfying sexual events, and decrease distress associated with HSDD.2,3,4 Addyi is a non-hormonal, multifunctional serotonin agonist antagonist (MSAA). Specifically a serotonin 1A agonist and a serotonin 2A antagonist. Though the exact mechanism of action of Addyi in the treatment of HSDD is not understood, Addyi theoretically improves sexual functioning by enhancing downstream release of dopamine and norepinephrine while reducing serotonin release in the brain circuits that mediate symptoms of reduced sexual interest and desire.5

Arrow pointing up sexual desire

Graph - Improvement in FSFI-D Score

Sexual Desire—measured using the Desire Domain of the Female Sexual Function Index (FSFI-D)

  • The FSFI-D was used to measure change from baseline in desire as a co-primary endpoint in Study 3, and as a secondary endpoint in Studies 1 and 2
  • The FSFI-D consists of 2 questions: "Over the past 4 weeks, how often did you feel sexual desire or interest?" and "Over the past 4 weeks, how would you rate your level of sexual desire or interest?"
  • A score of ≤3 may indicate the presence of HSDD6,7

†P value not reported for secondary endpoints.

Arrow pointing up satisfying sexual events

Graph - Increase in number of SSEs

Satisfying Sexual Events (SSEs)

  • Studies 1, 2, and 3 measured number of SSEs as a co-primary endpoint
  • SSEs included sexual intercourse, oral sex, masturbation, or genital stimulation by a partner

Arrow pointing down associated distress

Graph - Improvements in distress associated with low sexual desire

Decrease in Distress—measured using the Female Sexual Distress Scale–Revised, Question 13 (FSDS-R, Q13)

  • Studies 1, 2, and 3 measured the decrease in distress with the FSDS-R, Q13 as a secondary endpoint
  • The FSDS-R, Q13 measures Bother—a component of distress—based on the question, "How often did you feel bothered by low sexual desire?"

†P value not reported for secondary endpoints.

Safety Profile for Addyi

The approved 100 mg dose of Addyi was administered to 2997 premenopausal women with acquired, generalized HSDD, of whom 1672 received Addyi for at least 6 months.

Adverse reactions leading to discontinuation

The discontinuation rate due to adverse reactions was 13% among patients treated with 100mg Addyi at bedtime and 6% among patients treated with placebo.

Adverse reactions* leading to discontinuation in 4 randomized, double-blind, placebo-controlled trials in premenopausal women with HSDD.

  Placebo (n=1556) Addyi (n=1543)
Dizziness 0.1% 1.7%
Nausea 0.1% 1.2%
Insomnia 0.2% 1.1%
Somnolence 0.3% 1.1%
Anxiety 0.3% 1.0%

*Adverse reactions leading to discontinuation of ≥1% of patients receiving 100 mg Addyi at bedtime and at a higher incidence than placebo-treated patients.

Most common adverse reactions

Common adverse reactions in 4 randomized, double-blind, placebo-controlled trials in premenopausal women with HSDD.

The majority of these adverse reactions began within the first 14 days of treatment.

  Placebo (n=1556) Addyi (n=1543)
Dizziness 2.2% 11.4%
Nausea 2.9% 11.2%
Insomnia 3.9% 10.4%
Somnolence 5.5% 9.2%
Anxiety 2.8% 4.9%
Dry mouth 1.0% 2.4%

Adverse reactions reported in ≥2% of patients receiving 100 mg Addyi at bedtime and at a higher incidence than placebo-treated patients.

Study Design: The efficacy of Addyi for the treatment of HSDD in premenopausal women was established in three 24-week, randomized, double-blind, placebo-controlled trials. The 3 trials included premenopausal women with acquired, generalized HSDD of at least 6 months’ duration. The patients were treated with Addyi 100 mg once daily at bedtime (n=1187) or placebo (n=1188).

References: 1. Clayton AH, Goldfischer ER, Goldstein I, DeRogatis L, Lewis‐D'Agostino DJ, and Pyke R. Validation of the Decreased Sexual Desire Screener (DSDS): A brief diagnostic instrument for generalized acquired female Hypoactive Sexual Desire Disorder (HSDD). J Sex Med 2009;6:730–738. 2. DeRogatis LR, Komer L, Katz M, et al; VIOLET trial investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET study. J Sex Med. 2012;9(4):1074-1085. 3. Thorp J, Simon J, Dattani D, et al; DAISY trial investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med. 2012;9(3):793-804. 4. Katz M, DeRogatis LR, Ackerman R, et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med. 2013;10(7):1807-1815. 5. Stephen M. Stahl Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorder. CNS Spectrums, Available on CJO 2015 doi:10.1017/S1092852914000832 6. Gerstenberger EP, Rosen RC, Brewer JV, et al. Sexual desire and the Female Sexual Function Index (FSFI): a sexual desire cutpoint for clinical interpretation of the FSFI in women with and without hypoactive sexual desire disorder. J Sex Med. 2010;7(9):3096–3103. 7. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191-208.

Setting Patient Expectations

Pill

Addyi 100 mg is taken orally as a once-daily pill at bedtime.

Bedtime

Bedtime dosing is important. Addyi taken at a time other than bedtime can increase the risk of hypotension, syncope, and somnolence. If a dose of Addyi is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day.

Calendar

Patients may begin to see results in as early as 4 weeks. Patients should discontinue use if they do not see any improvement in their symptoms after 8 weeks.

Cancel

Addyi is contraindicated in patients taking moderate or strong CYP3A4 inhibitors because concomitant use increases Addyi concentrations, which can cause severe hypotension and syncope.

Cancel

Addyi is contraindicated with alcohol use, because the use of Addyi and alcohol increases the risk of severe hypotension and syncope.

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Addyi is contraindicated in patients with hepatic impairment.

Patient Savings and Home Delivery

Piggy Bank Savings

For patients with insurance coverage of Addyi, the cost is as little as $25/month (less than $1/day). Patients whose insurer does not cover Addyi, or those paying cash, will pay no more than $99/month for their Addyi prescription through the free home delivery* option.

Delivery Box Free Delivery

Your patient can get free home delivery* of Addyi at the lowest cost through PillPack Pharmacy, should their insurer not cover the medication. No special coupon is required. You can e-prescribe Addyi to PillPack Pharmacy NCPDP: 3061582.

*Delivery within the continental United States only, does not include Alaska or Hawaii.

Become REMS Certified

Only REMS certified healthcare providers and pharmacies can prescribe/distribute Addyi. If you are interested in becoming certified, there is a simple, 3-step process that can be completed online by clicking here

Free home delivery from a REMS certified specialty pharmacy is an option for your patients.For patients whose insurance does not cover Addyi, this is the least expensive option. You may e-prescribe Addyi to PillPack Pharmacy NCPDP: 3061582.

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