The efficacy of Addyi was established in three 24-week, randomized, double-blind, placebo-controlled trials in premenopausal women with acquired, generalized HSDD. Participants were age 19-55 years (mean 36 years) with an average HSDD and relationship duration of 5 years and 11 years, respectively. Approximately 40% subjects were also taking hormonal contraceptives. Women in these trials were treated with Addyi 100mg (n=1187) once-daily at bedtime, or placebo (n=1188).

Study 1 Study 2 Study 3
ADDYI (n=280)
Placebo (n=290)
ADDYI (n=365)
Placebo (n=372)
ADDYI (n=532)
Placebo (n=536)
Co-primary endpoints SSEs
eDiary Desire
SSEs
eDiary Desire
SSEs
FSFI-D
Secondary endpoints FSFI-D
FSDS-R Q13
FSFI-D
FSDS-R Q13
FSDS-R Q13

SSEs = satisfying sexual events; FSFI-D = Female Sexual Function Index – Desire Domain; FSDS-R Q13 = Female Sexual Distress Scale-Revised Question 13

IN CLINICAL TRIALS ALL 3 ENDPOINTS WERE MET

null

INCREASED Sexual Desire4-7

Sexual Desire measured Using Female Sexual Function Index Desire (FSFI-D) Domain

  • FSFI-Desire domain was a co-primary endpoint in Study 3, and 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?”8,9
    • A score of ≤3 may indicate the presence of HSDD8,9
    • Sexual desire began to increase between weeks 4 and 8 and the improvement was sustained through week 24

Sexual Desire – Measured Using E-Diary

  • Studies 1 and 2 measured desire using eDiary scores as a co-primary endpoint
    • Every day, patients rated their level of sexual desire from a scale of 0 to 3
    • The eDiary responses were summed over a 28-day period to yield the calculated monthly sexual desire score, which ranged from 0 to 84
    • P value not reported for secondary endpoints because the trial failed on the eDiary desire co-primary efficacy endpoint
null
INCREASED SATISFYING SEXUAL EVENTS (SSEs)4-7
  • Studies 1, 2, and 3 measured number of monthly SSEs as a co-primary endpoint
  • SSEs included sexual intercourse, oral sex, masturbation, or genital stimulation by a partner
  • SSEs began to increase between weeks 4 and 8 and the improvement was sustained through week 24
null

REDUCED Distress ASSOCIATED WITH LOW SEXUAL DESIRE4-7

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 distress based on the question, “How often did you feel bothered by low sexual desire?”
  • Distress with associated low desire began to decrease between weeks 4 and 8 and the improvement was sustained through week 24

**Pooled analysis of studies 1,2,and 3.

CLINICAL TRIAL safety profile4

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 are shown below.

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%
Somnolence 2.9% 11.2%
Nausea 3.9% 10.4%
Fatigue 5.5% 9.2%
Insomnia 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.

Additional Data

POST HOC ANALYSIS OF FEMALE SEXUAL FUNCTION INDEX (FSFI)11

Post hoc analyses of FSFI total and individual domain data were pooled from 3 pivotal, multicenter, randomized, placebo-controlled, double-blind trials in premenopausal women with HSDD who received flibanserin (n=1165) or placebo (n=1203). Addyi has not been studied for the treatment of any female dysfunction other than acquired, generalized HSDD.

Post Hoc Analysis of FSFI Domain Scores

  • Post-hoc exploratory analyses compared change from baseline in FSFI scores of flibanserin and placebo groups at each assessment time point by t-test
    • FSFI questionnaire was administered at baseline and Weeks 4, 8, 16, and 24
    • There was no adjustment for multiple comparisons
    • Missing data were handled using the last observation carried forward (LOCF) method

‡Post hoc analysis sponsored by Sprout.

POST HOC ANALYSIS OF EFFECT ON WEIGHT12

Post hoc analysis of pooled data from 3 pivotal, multicenter, randomized, placebo-controlled, double-blind trials in premenopausal women with HSDD who received flibanserin. Addyi is not indicated for weight loss.

Portion of Patients with > 5-10% Weight Loss at 24 Weeks

Post Hoc Analysis of Pooled Data from 3 Clinical Trials in Premenopausal Women with HSDD

  • Mean baseline weight was ~73kg (~160lbs)
  • Weight gain ≥7% at 24 weeks occurred in 1.8% women receiving flibanserin and 3.4% women receiving placebo
  • Higher baseline BMI was associated with greater weight loss.
  • No association seen between effect on weight and treatment response, contraceptive use, smoking status, SSRI/SNRI use, or occurrence of nausea
  • Body weight was measured to assess weight loss and weight gain as potential adverse events
  • Study was not designed to evaluate weight loss. Patients were not selected based on obesity status nor did they enter the studies with the goal of losing weight.

COADMINISTRATION WITH SSRI/SNRI

Clinical considerations for taking Addyi with SSRIs and SNRIs

CONTRAINDICATED4
Fluvoxamine (Luvox)
  • Fluvoxamine is a moderate CYP3A4 inhibitor13
Citalopram (Celexa)
Escitalpram (Lexapro)
Fluoxetine (Prozac)
Paroxetine (Paxil)
Sertaline (Zoloft)
Vilazodone (Viibryd)
Desvenlafaxine (Pristiq)
Duloxetine (Cymbalta)
Levomilnacipran (Fetzima)
Milnasipran (Savella)
Venlafaxine (Effexor)
PATIENT COUNSELING RECOMMENDED4,13
  • Fluvoxamine is a strong CYP2C19 inhibitor and weak CYP3A4 inhibitor and may increase filbanserin exposure.
  • Concomitant administration with other CNS-acting agents such as SSRI/SNRIs may increase CNS depression
ADVISE PATIENTS
  • Concomitant administration may increase risk of adverse reactions.
  • Addyi can cause severe hypotension, syncope and CNS depression (such as somnolence and sedation). The risk is increased if Addyi taken during waking hours.
  • Addyi should be taken only one tablet at bedtime and not any other time of day.
CONTRAINDICATED4
Fluvoxamine (Luvox)
  • Fluvoxamine is a moderate CYP3A4 inhibitor13
Citalopram (Celexa)
Escitalpram (Lexapro)
Fluoxetine (Prozac)
Paroxetine (Paxil)
Sertaline (Zoloft)
Vilazodone (Viibryd)
Desvenlafaxine (Pristiq)
Duloxetine (Cymbalta)
Levomilnacipran (Fetzima)
Milnasipran (Savella)
Venlafaxine (Effexor)
PATIENT COUNSELING RECOMMENDED4,13
  • Fluvoxamine is a strong CYP2C19 inhibitor and weak CYP3A4 inhibitor and may increase filbanserin exposure.
  • Concomitant administration with other CNS-acting agents such as SSRI/SNRIs may increase CNS depression
ADVISE PATIENTS
  • Concomitant administration may increase risk of adverse reactions.
  • Addyi can cause severe hypotension, syncope and CNS depression (such as somnolence and sedation). The risk is increased if Addyi taken during waking hours.
  • Addyi should be taken only one tablet at bedtime and not any other time of day.

Information based on pharmacologic action of products based on respective Prescribing Information as of May 2021. All product names, trademarks and registered trademarks are property of their respective owners.

SAFETY STUDY WITH SSRI/SNRI14

12 week randomized, double-blind, placebo-controlled clinical trial in 111 premenopausal women with mild to remitted depression treated with a stable dose of SSRI/SNRI* and symptoms of HSDD.**

RESULT

Filbanserin† +
SSRI/SNRI (%) N=72

Placebo +
SSRI/SNRI (%) N=37
Primary endpoint
Incidence AEs
65.8 71.1
Depression
(QIDS-SR16)
Remission
No change
Worsened
19.4
73.6
6.9
10.8
67.6
21.6
Anxiety
(Beck Anxiety Inventory)
Remission
No change
Worsened
16.4
82.2
1.4
2.7
94.6
2.7
RESULT Filbanserin† +
SSRI/SNRI (%) N=72
Placebo +
SSRI/SNRI (%) N=37
Primary endpoint
Incidence AEs
65.8 71.1
Depression
(QIDS-SR16)
Remission
No change
Worsened
19.4
73.6
6.9
10.8
67.6
21.6
Anxiety
(Beck Anxiety Inventory)
Remission
No change
Worsened
16.4
82.2
1.4
2.7
94.6
2.7
  • Overall, no increased risk of adverse events, including depression and anxiety were observed
  • No instances of suicidality (C-SSRS)
  • AEs ≥3% with Addyi and higher than placebo: dry mouth, insomnia, back pain, dizziness
  • This study was designed to assess flibanserin safety; No conclusions regarding efficacy can be made

*citalopram, escitalopram, fluoxetine, paroxetine, sertraline, desvenlafaxine, duloxetine, venlafaxine
**Planned sample size was 200 patients; study was terminated early due to commercial reasons
†Includes 28 patients on fixed 100 mg qhs dose and 45 patients on up-titrated dose (50 mg qhs first two weeks, followed by 100 mg qhs).
C-SSRS = Columbia-Suicide Severity Rating Scale; QIDS-SR16 = 16-item Quick Inventory of Depressive Symptomology-Self Report

CLINICALLY SIGNIFICANT

DRUG INTERACTIONS WITH ADDYI4

Alcohol
Clinical Implications The coadministration of ADDYI with alcohol increased the risk of hypotension syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone.
Preventing or Managing DI 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.
Other CNS Depressants
Examples Diphenhydramine, opioids, hypnotics, benzodiazepines
Clinical Implications The concomitant use of ADDYI with CNS depressants may increase the risk of CNS depression (e.g., somnolence) compared to the use of ADDYI alone.
Preventing or Managing DI Discuss the concomitant use of other CNS depressants with the patient when prescribing ADDYI.
Moderate or Strong CYP3A4 Inhibitors
Examples of strong
CYP3A4 Inhibitors
Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, squinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, and conivaptan
Examples of moderate
CYP3A4 Inhibitors
Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice
Clinical Implications The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors increases flibanserin exposure compared to the use of ADDYI alone. The risk of hypotension and syncope is increased with concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors.
Preventing or Managing DI The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors is contraindicated.
Weak CYP3A4 Inhibitors
Examples Oral contraceptives, cimetidine, fluxetine, ginkgo, ranitidine
Clinical Implications The concomitant use of ADDYI with multiple weak CYP3A4 inhibitors may increase the risk of adverse reactions.
Preventing or Managing DI Discuss the use of multiple weak CYP3A4 inhibitors with the patient when prescribing ADDYI.
Strong CYP2C19 Inhibitors
Examples Proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, antifungals
Clinical Implications The concomitant use of ADDYI with strong CYP2C19 inhibitors may increase flibanserin exposure which may increase the risk of hypotension, syncope, and CNS depression.
Preventing or Managing DI Discuss the use of a strong CYP2C19 inhibitor with the patient when prescribing ADDYI.
CYP3A4 Inducers
Examples Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John’s Wort
Clinical Implications The concomitant use of ADDYI with CYP3A4 inducers substantially decreases flibanserin exposure compared to the use of ADDYI alone.
Preventing or Managing DI The concomitant use of ADDYI with CYP3A4 inducers is not recommended.
Digoxin or Other P-glycoprotein Substrates
Examples Digoxin, Sirolimus
Clinical Implications The concomitant use of ADDYI with digoxin, a drug that is transported by P-glycoprotein (P-gp), increases the digoxin concentration. This may lead to digoxin toxicity.
Preventing or Managing DI Increase monitoring of concentrations of drugs transported by P-gp that have a narrow therapeutic index (e.g., digoxin).
Alcohol
Clinical Implications The coadministration of ADDYI with alcohol increased the risk of hypotension syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone.
Preventing or Managing DI 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.
Other CNS Depressants
Examples Diphenhydramine, opioids, hypnotics, benzodiazepines
Clinical Implications The concomitant use of ADDYI with CNS depressants may increase the risk of CNS depression (e.g., somnolence) compared to the use of ADDYI alone.
Preventing or Managing DI Discuss the concomitant use of other CNS depressants with the patient when prescribing ADDYI.
Moderate or Strong CYP3A4 Inhibitors
Examples of strong
CYP3A4 Inhibitors
Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, squinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, and conivaptan
Examples of moderate
CYP3A4 Inhibitors
Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice
Clinical Implications The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors increases flibanserin exposure compared to the use of ADDYI alone. The risk of hypotension and syncope is increased with concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors.
Preventing or Managing DI The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors is contraindicated.
Weak CYP3A4 Inhibitors
Examples Oral contraceptives, cimetidine, fluxetine, ginkgo, ranitidine
Clinical Implications The concomitant use of ADDYI with multiple weak CYP3A4 inhibitors may increase the risk of adverse reactions.
Preventing or Managing DI Discuss the use of multiple weak CYP3A4 inhibitors with the patient when prescribing ADDYI.
Strong CYP2C19 Inhibitors
Examples Proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, antifungals
Clinical Implications The concomitant use of ADDYI with strong CYP2C19 inhibitors may increase flibanserin exposure which may increase the risk of hypotension, syncope, and CNS depression.
Preventing or Managing DI Discuss the use of a strong CYP2C19 inhibitor with the patient when prescribing ADDYI.
CYP3A4 Inducers
Examples Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John’s Wort
Clinical Implications The concomitant use of ADDYI with CYP3A4 inducers substantially decreases flibanserin exposure compared to the use of ADDYI alone.
Preventing or Managing DI The concomitant use of ADDYI with CYP3A4 inducers is not recommended.
Digoxin or Other P-glycoprotein Substrates
Examples Digoxin, Sirolimus
Clinical Implications The concomitant use of ADDYI with digoxin, a drug that is transported by P-glycoprotein (P-gp), increases the digoxin concentration. This may lead to digoxin toxicity.
Preventing or Managing DI Increase monitoring of concentrations of drugs transported by P-gp that have a narrow therapeutic index (e.g., digoxin).

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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING AND INDICATION

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 standard 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.

Contraindications

  • Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors
  • Hepatic impairment
  • Known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported.

Warnings and Precautions

  • Hypotension and Syncope Due to an Interaction with Alcohol: Taking ADDYI within two hours after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients to wait at least two hours after drinking one or two standard alcoholic drinks before taking ADDYI at bedtime. Patients who drink three or more standard alcoholic drinks should skip their ADDYI dose that evening. After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.
  • Hypotension and Syncope with CYP3A4 Inhibitors: Moderate or 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 (CNS) Depression (e.g., Somnolence, Sedation): Can occur with ADDYI alone and is exacerbated by other CNS depressants including alcohol, and in settings where flibanserin concentrations are increased such as CYP3A4 inhibitors. The risk of CNS depression is also increased if ADDYI is taken during waking hours. 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.
  • 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. The risk of hypotension and syncope is increased if ADDYI is taken during waking hours or if higher than the recommend 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 with pre-syncope should immediately lie supine and promptly seek medical help if 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 and syncope. ADDYI is contraindicated in patients with hepatic impairment.
  • Hypersensitivity Reactions: Reactions including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported with ADDYI. Immediately discontinue ADDYI and initiate appropriate treatment if hypersensitivity reaction occurs.

Drug Interactions

  • Alcohol: coadministration of ADDYI with alcohol increased the risk of hypotension, syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone. Patients should 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.
  • CNS Depressants: (i.e., diphenhydramine, opioids, hypnotics, benzodiazepines, etc.) Concomitant use with ADDYI may increase the risk of CNS depression compared to use of ADDYI alone.
  • Moderate or Strong CYP3A4 Inhibitors: ADDYI is contraindicated in women taking moderate (e.g., fluconazole, etc.) or strong (e.g., ketoconazole, etc.) CYP3A4 inhibitors.
  • Oral Contraceptives and Other Weak CYP3A4 Inhibitors: In combination with ADDYI may increase the risk of adverse reactions.
  • Strong CYP2C19 Inhibitors: (i.e., proton pump inhibitors, SSRI’s, benzodiazepines, antifungals, etc.) Increase flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression.
  • CYP3A4 Inducers: (i.e., carbamazepine, phenobarbital, etc.) Concomitant use substantially decreases flibanserin exposure compared to the use of ADDYI alone and is not recommended.
  • Digoxin or other P-glycoprotein (P-gp) substrates: Increases digoxin concentration, which may lead to digoxin toxicity. Increase monitoring of drugs transported by P-gp that have a narrow therapeutic index.

Most Common Adverse Reactions

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

See Full Prescribing Information and Medication Guide, including Boxed Warning regarding hypotension and syncope in certain settings at addyi.com/pi.

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 problem 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.
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