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

ADDYI IS THE ONLY FDA-APPROVED NON-HORMONAL TREATMENT 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

The 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.6

The 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.6

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).

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, REMS certified 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, REMS Certified 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.

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)7,8,9

  • 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 HSDD10,11
null

ADD
Satisfying Sexual Events

Satisfying Sexual Events (SSEs)7,8,9

  • 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)7,8,9

  • 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.12

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).

SETTING PATIENT EXPECTATIONS

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. Patients should be advised to discontinue drinking alcohol at least two hours before taking Addyi at bedtime.

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 prescribed ADDYI about the importance of waiting at least two hours after consuming alcohol before taking ADDYI.
  • 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.

Addyi is contraindicated:

  • With concomitant use with moderate or strong CYP3A4 inhibitors.
  • In patients with hepatic impairment.

Summary of Warnings and Precautions

  • Hypotension and Syncope due to an Interaction with Alcohol. An interaction between ADDYI and alcohol when consumed close in time increases the risk of severe hypotension and syncope. Counsel patients to wait at least two hours after consuming alcohol before taking ADDYI at bedtime. Alternatively, counsel patients to skip the ADDYI dose at bedtime if the patient consumes alcohol in the evening. After taking ADDYI at bedtime, advise patients not to use alcohol until the following day.
  • Hypotension and Syncope with CYP3A4 Inhibitors. 
Moderate and strong CYP3A4 inhibitors significantly increase ADDYI concentrations, which can lead to hypotension and syncope. Concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated.

 Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope.
  • Central Nervous System Depression. ADDYI can cause CNS depression (e.g., somnolence, sedation). In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD the incidence of somnolence, sedation, or fatigue was 21% and 8% in patients treated with 100 mg of ADDYI at bedtime and placebo, respectively. The risk of CNS depression is increased if ADDYI is taken during waking hours, or if ADDYI is taken with alcohol or other CNS depressants, or with medications that increase flibanserin concentrations.
Patients should not drive or engage in other activities requiring full alertness until at least 6 hours after taking ADDYI and until they know how ADDYI affects them.
  • Hypotension and Syncope with Addyi Alone. The use of ADDYI – without other concomitant medications known to cause hypotension or syncope – can cause hypotension and syncope. In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, hypotension was reported in 0.2% and <0.1% of ADDYI-treated patients and placebo-treated patients, respectively; syncope was reported in 0.4% and 0.2% of ADDYI-treated patients and placebo-treated patients, respectively. The risk of hypotension and syncope is increased if ADDYI is taken during waking hours or if higher than the recommended dose is taken. Consider the benefits of ADDYI and the risks of hypotension and syncope in patients with pre-existing conditions that predispose to hypotension. Patients who experience pre-syncope should immediately lie supine and promptly seek medical help if the symptoms do not resolve. Prompt medical attention should also be obtained for patients who experience syncope.
  • Syncope and Hypotension in Patients with Hepatic Impairment.  Any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension, syncope, and CNS depression. Therefore, ADDYI is contraindicated in patients with hepatic impairment.

Most Common Adverse Reactions

  • The most common adverse reactions (reactions reported in ≥2% of patients receiving 100 mg ADDYI and at a higher incidence than placebo-treated subjects): dizziness (11.4%; 2.2%), somnolence (11.2%; 2.9%), nausea (10.4%; 3.9%), fatigue (9.2%; 5.5%), insomnia (4.9%; 2.8%), and dry mouth (2.4%; 1.0%).

Summary of Drug Interactions

  • Addyi is primarily metabolized by CYP3A4 and, to a lesser extent, by CYP2C19.

  • Addyi is contraindicated in women taking a moderate (e.g., fluconazole) or strong (e.g., ketoconazole) CYP3A4 inhibitor.
  • The concomitant use of Addyi with CNS depressants (e.g., diphenhydramine, opioids, hypnotics, benzodiazepines) may increase the risk of CNS depression (e.g., somnolence) compared to use of Addyi alone.
  • Patients using Addyi with combined oral contraceptives or with weak CYP3A4 inhibitors may experience a higher incidence of adverse reactions.
  • Strong CYP2C19 inhibitors (e.g., proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, antifungals) may increase Addyi exposure, which may increase the risk of hypotension, syncope, and CNS depression.
  • Do not use Addyi with strong CYP3A4 inducers (e.g., rifampin, St. John’s Wort) as this will substantially reduce the concentration of Addyi.
  • Addyi inhibits P-glycoprotein (P-gp). Monitoring of drug concentrations of any narrow therapeutic index drugs that are substrates for P-gp (e.g., digoxin, sirolimus) should be increased if co-administered with Addyi. The concomitant use of Addyi with digoxin, a drug that is transported by P-gp, increases the digoxin concentration. This may lead to digoxin toxicity.

See FULL PRESCRIBING INFORMATION, including Boxed Warning regarding the use of alcohol, hypotension, and syncope in certain settings.

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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 – – 1900020.06

*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. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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