Flibanserin Availability
Flibanserin (Addyi) is FDA-approved and available in the United States for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. 1, 2
Regulatory Status
Flibanserin received FDA approval in August 2015 for acquired, generalized HSDD in premenopausal women. 3, 1
The drug is marketed under the brand name Addyi™ by Sprout Pharmaceuticals in the United States. 1, 4
Earlier phase III development in the EU and Canada was discontinued by Boehringer Ingelheim following regulatory feedback, meaning the drug is not approved in these jurisdictions. 1
Important Availability Limitations
The FDA approval is specifically limited to premenopausal women only, though research has demonstrated efficacy in postmenopausal women as well. 1, 5
A Risk Evaluation and Mitigation Strategy (REMS) program was initially required in the US, though this has been simplified over time to increase prescriber access. 2
The drug requires a prescription from healthcare providers who understand its risk-benefit profile, particularly regarding sedation and hypotension-related adverse events. 2
Clinical Context for Use
Flibanserin is recommended in NCCN guidelines for discussion with patients experiencing low or lack of desire, libido, or intimacy, particularly in cancer survivors. 3
The drug has not been studied in women with cancer or those on endocrine therapy, and the risk/benefit ratio in these populations remains uncertain. 3
Common adverse effects include dizziness, somnolence, nausea, and fatigue, which are typical of centrally acting medications and should be discussed with patients. 3, 6
Daily dosing is required (100 mg/day), and the medication may be used long-term, potentially for a decade or more in typical premenopausal patients. 6, 2
Geographic Availability Summary
If you are asking about availability in the United States: Yes, flibanserin is FDA-approved and available by prescription. 1, 2
If you are asking about availability in Canada or the European Union: No, flibanserin is not approved in these regions as development was discontinued. 1
For other locations not mentioned in the evidence, you would need to check with local regulatory authorities, as the available evidence only confirms US approval and EU/Canada non-approval.