It’s Time To Undo Her Distress Around Her Sexual Desire

ADDYI IS THE ONLY FDA-APPROVED NON-HORMONAL PILL FOR ACQUIRED, GENERALIZED HSDD IN PREMENOPAUSAL WOMEN

Hypoactive Sexual Desire Disorder (HSDD) is the most common form of female sexual dysfunction.1 It’s characterized by:

  • Chronically low sexual desire (which your patients may call low libido or low sex drive)
  • Associated personal distress

HER BRAIN MAY BE WORKING AGAINST HER WHEN IT COMES TO SEX

HSDD is a condition that has been medically recognized for nearly half a century,2 and it is believed to be caused by an imbalance of chemicals in the brain. Brain scan studies have demonstrated that there is a significant difference in the regulation of human sexual response in women who suffer from HSDD compared to those who don’t.

During these functional MRI studies, when women with normal sexual function were shown erotic cues, multiple areas of their brains appeared activated. In comparison, women with HSDD exhibited a different pattern of brain activation— specifically among the areas known for inhibition and attention. This suggests that areas of sexual response are monitored or suppressed in women with HSDD.3,4,5

HER BRAIN MAY BE WORKING AGAINST HER WHEN IT COMES TO SEX

HSDD is a condition that has been medically recognized for nearly half a century,2 and it is believed to be caused by an imbalance of chemicals in the brain. Brain scan studies have demonstrated that there is a significant difference in the regulation of human sexual response in women who suffer from HSDD compared to those who don’t.

During these functional MRI studies, when women with normal sexual function were shown erotic cues, multiple areas of their brains appeared activated. In comparison, women with HSDD exhibited a different pattern of brain activation— specifically among the areas known for inhibition and attention. This suggests that areas of sexual response are monitored or suppressed in women with HSDD.3,4,5

73% of patients want YOU
to start the conversation.6
This conversation begins
with a valid screener.

DIAGNOSING HSDD IS SIMPLE

As her healthcare provider, it’s important for you to lead the dialogue around her sexual health concerns. Along with a patient interview, you can use the Decreased Sexual Desire Screener (DSDS), to help efficiently determine if she has HSDD. The DSDS is a validated medical questionnaire with just 5 simple questions.7

73% of patients want YOU
to start the conversation.6
This conversation begins
with a valid screener.

DIAGNOSING HSDD IS SIMPLE

As her healthcare provider, it’s important for you to lead the dialogue around her sexual health concerns. Along with a patient interview, you can use the Decreased Sexual Desire Screener (DSDS), to help efficiently determine if she has HSDD. The DSDS is a validated medical questionnaire with just 5 simple questions.7

SETTING PATIENT EXPECTATIONS

Patients may begin to see results in as early as 4 weeks. Signs that her desire is returning include thinking about or fantasizing about having sex, wanting to have a sexual experience, and being receptive to a partner’s sexual initiation.

Addyi 100 mg is a once-daily, non-hormonal pill taken at 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.

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.

In order to give your patients the recommended amount of time to see if they will be a responder to Addyi, they will get the first two months of Addyi FREE, regardless of insurance coverage. Learn more about patient savings here.

Alcohol may be consumed while taking Addyi. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening.

TWO WAYS FOR PATIENTS TO SAVE

Prescribe Addyi

Free Delivery With Specialty Pharmacy

Addyi can be delivered directly to her doorstep free of charge using a specialty pharmacy (KnippeRx). No coupon code or card required. You can e-prescribe Addyi to KnippeRx Pharmacy NCPDP: 1568560. For any questions, contact KnippeRx directly at 877-809-3141.

Addyi Savings
Card

If she prefers to pick up her prescription at a local pharmacy, direct her to the Addyi Savings Card website at addyi.com/savings. To activate her savings, instruct her to fill in the required information and present the card (either on their phone or via a print out) to her pharmacist.

TWO WAYS FOR PATIENTS TO SAVE

Prescribe Addyi

Free Delivery With Specialty Pharmacy

Addyi can be delivered directly to her doorstep free of charge using a specialty pharmacy (KnippeRx). No coupon code or card required. You can e-prescribe Addyi to KnippeRx Pharmacy NCPDP: 1568560. For any questions, contact KnippeRx directly at 877-809-3141.

Addyi Savings
Card

If she prefers to pick up her prescription at a local pharmacy, direct her to the Addyi Savings Card website at addyi.com/savings. To activate her savings, instruct her to fill in the required information and present the card (either on their phone or via a print out) to her pharmacist.

ADDYI IS AFFORDABLE AND COVERED
BY MOST INSURANCE

All of your patients will receive their first 8 weeks of Addyi FREE, regardless of insurance coverage. This allows them the recommended amount of time to see how well they will respond to Addyi.

Subsequent refills will be no more than $25/month (less than $1/day). If their commercial insurance does not cover Addyi, or if they pay cash, subsequent refills will be no more than $99/month out of pocket for their prescription (less than $4 per day).

3 Clinical Trials:
3 Primary Endpoints Met

In Phase 3 clinical trials, Addyi was studied in 2,375 female participants (n = 1177 Addyi; n = 1198 placebo) and proven to increase sexual desire, increase satisfying sexual events, and decrease distress associated with HSDD with statistical significance.

ADD

sexual desire

ADD

number of satisfying sexual events

REDUCE

associated distress

null

ADD
Sexual Desire

Sexual Desire—measured using the Desire Domain of the Female Sexual Function Index (FSFI-D) 8,9,10

  • 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 HSDD11,12
null

ADD
Satisfying Sexual Events

Satisfying Sexual Events (SSEs) 8,9,10

  • 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
null

REDUCE
Associated Distress

Decrease in Distress—measured using the Female Sexual Distress Scale–Revised, Question 13 (FSDS-R, Q13) 8,9,10

  • 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?”

HOW DOES ADDYI WORK?

Addyi is a non-hormonal, multifunctional serotonin agonist and 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.13

SAFETY PROFILE FOR ADDYI

The approved 100 mg dose of Addyi was administered to 2,997 premenopausal women with acquired, generalized HSDD.

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.

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.

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

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

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.

§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.

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=1177) or placebo (n=1198).

ADDYI CONTRAINDICATIONS

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

Addyi is contraindicated in patients with hepatic impairment.

Contact Us

844-PINK-PILL
(844-746-5745)

info@sproutpharma.com

Indication and Important Safety Information, including Boxed Warning

INDICATION

Addyi® (flibanserin) is indicated 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 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.

Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner.

Limitations of Use

  • Addyi is not indicated for the treatment of HSDD in postmenopausal women or in men.
  • Addyi is not indicated to enhance sexual performance.

IMPORTANT SAFETY INFORMATION

WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS

See full prescribing information for complete boxed warning.

  • Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope.  Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more alcoholic drinks that evening.
  • Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated.

Indications and Usage

ADDYI is indicated 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 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.

Limitations of Use:

  • ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men.
  • ADDYI is not indicated to enhance sexual performance.

Contraindications

  • Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors
  • Hepatic impairment

Warnings and Precautions

  • Hypotension and Syncope Due to an Interaction with Alcohol:  After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day.
  • Hypotension and Syncope with ADDYI Alone:  Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve.
  • Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation):  Can occur with ADDYI alone.  Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased.  Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least six hours after each dose and until they know how ADDYI affects them.

Adverse Reactions

Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.

To report SUSPECTED ADVERSE REACTIONS, contact Sprout Pharmaceuticals, Inc. at 1-844-746-5745, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug Interactions

  • Oral Contraceptives and Other Weak CYP3A4 Inhibitors:  Increases flibanserin exposure and incidence of adverse reactions
  • Strong CYP2C19 Inhibitors:  Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression
  • CYP3A4 Inducers:  Use of ADDYI not recommended; flibanserin concentrations substantially reduced
  • Digoxin:  Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.

Use in Specific Populations

  • Nursing Mothers:  ADDYI is not recommended.
  • CYP2C19 Poor Metabolizers:  Increases flibanserin exposure which may increase hypotension, syncope, and CNS depression.

PRIVACY POLICY | LEGAL NOTICE

This site is intended for US healthcare professionals only.

Addyi is a registered trademark of Sprout Pharmaceuticals, Inc. or its affiliates. All other trademarks are the property of their respective owners.

© 2019 Sprout Pharmaceuticals, Inc. US – – 1900020.07

*eligible patients

References

1. Shifren JL, Monz BU, Russo PA, et al. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008;112(5):970-8.

2. Helen Singer Kaplan MD, PhD (1977) Hypoactive sexual desire, Journal of Sex & Marital Therapy, 3:1, 3-9, DOI: 10.1080/00926237708405343

3. Arnow BA, Millheiser L, Garrett A, et al. Women with hypoactive sexual desire disorder compared to normal females: A functional magnetic resonance imaging study. Neuroscience. 2009; 158:484-502.

4. Woodard TL, Nowak NT, Balon R, Diamond MP. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: A cross-sectional pilot study. Fertil Steril. 2013; 100(4): 1068-1076.

5. Holstege G, Weijmar- Schultz W. How combined serotonin-1A receptor agonist and 2A- receptor antagonist can heal hypoactive sexual desire disorder (HSDD). Poster presented at Neuroscience 2014 the Society for Neuroscience 2014 Annual Meeting (SfN); November 15-19, 2014; Washington, DC.

6. Association of Reproductive Health Professionals ARHP and Healthy Women (2009). Women’s Sexual Health Survey (online in the US). Harris Interactive.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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