ADDYI
Addyi is indicated for the treatment of women under 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD). This condition is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to co-existing medical or psychiatric conditions, relationship problems, or the effects of other medications. The therapy is specifically for patients who previously had no issues with sexual desire and whose current condition occurs regardless of the type of stimulation, situation, or partner. Addyi is not indicated for use in men or for the enhancement of sexual performance.
How ADDYI Works
The mechanism of action of Addyi in the treatment of women with acquired, generalized hypoactive sexual desire disorder is not known. The provided clinical information does not identify a specific biological target or describe how the drug produces its therapeutic effect through activation or inhibition. Consequently, the biological pathways involved in how the drug addresses low sexual desire remain unestablished.
Details
- Status
- Prescription
- First Approved
- 2015-08-18
- Routes
- ORAL
- Dosage Forms
- TABLET
ADDYI Approval History
What ADDYI Treats
1 indicationsADDYI is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoactive Sexual Desire Disorder
ADDYI Boxed 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 Inhibito...
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 )
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADDYI FDA Label Details
ProIndications & Usage
FDA Label (PDF)ADDYI is indicated for the treatment of women less than 65 years of age 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 ...
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 standar...
ADDYI Patents & Exclusivity
Patents (1 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.