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Addyi (FLIBANSERIN)
Addyi works by increasing the levels of neurotransmitters dopamine, serotonin, and norepinephrine in the brain, which helps to regulate sexual desire.
Addyi (Flibanserin) is a small molecule modality developed by Sprout Pharmaceuticals Inc, currently owned by Sprout Pharms. It targets the 5-hydroxytryptamine receptor 1A and was FDA-approved in 2015 for the treatment of lack or loss of sexual desire. Addyi is a patented medication with no generic manufacturers available. Key safety considerations include its potential to interact with other medications and cause dizziness, nausea, and fatigue. Its commercial status is patented.
At a glance
| Generic name | FLIBANSERIN |
|---|---|
| Sponsor | Sprout Pharms |
| Target | 5-hydroxytryptamine receptor 1A |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
The mechanism of action of ADDYI in the treatment of premenopausal women with hypoactive sexual desire disorder is not known.
Approved indications
- Lack or loss of sexual desire
Boxed warnings
- WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS Interaction with Alcohol The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1) ]. 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. Contraindicated with Strong or Moderate CYP3A4 Inhibitors The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.2) ] . Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4) ] . Contraindicated in Patients with Hepatic Impairment The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.5) ] . Therefore, ADDYI is contraindicated in patients with hepatic impairment [see Contraindications (4) ] . 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. ( 4 , 5.1 ) • 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. ( 4 , 5.2 , 5.5 )
Common side effects
- Accidental exposure to product by child
- Therapeutic response unexpected
Key clinical trials
- Hypoactive Sexual Desire Disorder in Males (PHASE2)
- A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors (PHASE2)
- Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer (PHASE2)
- Effects of Flibanserin on the Pre- and Post-menopausal Female Brain (NA)
- Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy (PHASE4)
- Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA) (PHASE1)
- 12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress (PHASE3)
- 24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Addyi CI brief — competitive landscape report
- Addyi updates RSS · CI watch RSS
- Sprout Pharms portfolio CI