Addyi is the only FDA-Approved treatment that demonstrated effectiveness across all clinical trial endpoints.

In women with hypoactive sexual desire disorder, deactivation of their medial orbitofrontal cortex produces a decrease in PAG-POSC activation, causing absence of vaginal vasocongestion and lubrication and decreased sexual behavior in general. It often leads to major problems in their personal circumstances.1

Addyi has shown 5-HT1a agonist and %-HT2a antagonist activity in studies.2

1. Gert Holstege, How the Emotional Motor System Controls the Pelvic Organs, Sexual Medicine Reviews, Volume 4, Issue 4, 2016, Pages 303-3283 Stahl SM, et al. Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. J Sex Med. 2011;8:15-27A PET scan study examined 24 women (age 18-47) with and without HSDD by having them watch neutral, low, and high erotic movies for 2 minutes while lying with their head in a PET scanner. Results showed that the women with HSDD had little to no activation in areas of the brain that normally respond to sexual cues. Increased activation was also viewed in the prefrontal cortex, which blocks the progression of desire.

Beware the imitators.If the fine print on the package or website says the following, the product has NOT passed the safety or effectiveness standards required for FDA approval.

"I love my partner but I’ve lost that inner sexy I once felt. It’s not them, it’s not depression, it’s like an internal switch went out. I want to turn back on!”

– Melissa H, 38

Addyi once-daily 100mg dosage
demonstrates superiority over placebo

Addyi once-daily 100mg dosage
demonstrates superiority over placebo

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INCREASE HER
SEXUAL DESIRE

Click to review the full clinical data

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INCREASE HER
SEXUAL DESIRE

Click to review the full clinical data

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INCREASE HER SEXUALLY SATISFYING EVENTS

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INCREASE HER SEXUALLY SATISFYING EVENTS

Click to review the full clinical data

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Most Common Adverse Effects 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.

**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.

"After a few weeks on Addyi I felt like my old self again... I was even having fantasies! I could not wait until date night!”

– Erica S. 34

Addyi’s Additional Data

Post Hoc Analysis of FSFI Domain Scores

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=1204)

Orgasm

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Lubrication

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Arousal

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Pain

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Additional Data

POST HOC ANALYSIS OF EFFECT ON WEIGHT1

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.
Click to Learn More AboutCoadministration with SSRI/SNRI
Click to Learn More AboutSafety Study with SSRI/SNRI

"Addyi has impacted the way we approach women’s sexual health. Seeing my patients feel like themselves again has been incredibly rewarding.”

– Mona Gupta, DO

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.