FDA Advances Treatment for Hypoactive Sexual Desire Disorder in Postmenopausal Women
Flibanserin, a medication approved by the U.S. Food and Drug Administration (FDA) for treating hypoactive sexual desire disorder (HSDD) in premenopausal women, may soon be available for postmenopausal women as well. On July 24, 2025, the FDA granted Priority Review to an application for expanding the use of flibanserin (marketed as Addyi by Sprout Pharmaceuticals), sparking hope for millions of women experiencing low sexual desire during and after menopause.
Understanding Hypoactive Sexual Desire Disorder
HSDD is characterized by a persistent lack of sexual desire that causes distress or interpersonal difficulties. It is the most common female sexual health condition, affecting almost 40% of women at some point in their lives. Despite its prevalence, treatment options have traditionally been sparse, leaving women with few avenues for addressing this impactful condition.
Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, stated, “Sexual desire is ageless. Access to care should be too. Priority Review brings us closer to expanding access and empowering more women with a science-backed, FDA-approved solution for their sexual wellness.”
How Flibanserin Works
Flibanserin is a groundbreaking nonhormonal treatment for HSDD. It works by modulating neurotransmitters in the brain, such as dopamine and serotonin, which play a key role in sexual desire and response. Unlike hormonal therapies, flibanserin targets the central mechanisms of desire directly without altering estrogen or testosterone levels.
Since its initial FDA approval for premenopausal women, over 25,000 healthcare providers in the United States have prescribed flibanserin. The drug has also been approved for postmenopausal women in Canada, following comprehensive clinical trials demonstrating its safety and efficacy.
The Significance of FDA Priority Review
The FDA’s Priority Review designation underscores the importance of addressing HSDD in postmenopausal women. This expedited process is reserved for treatments that could significantly improve the management of serious conditions. Should the FDA approve flibanserin’s expanded use, it would mark a major step forward in recognizing and addressing the sexual health needs of women across all life stages.
Considerations and Risks
While flibanserin represents a significant advancement, it is not without risks. The medication can cause severe low blood pressure and fainting, particularly when combined with alcohol, certain medications, or in individuals with liver problems. Patients are advised to avoid alcohol within two hours of administration and to consult their healthcare providers about any potential interactions.
Other common side effects include dizziness, drowsiness, nausea, and dry mouth. Healthcare providers must carefully evaluate each patient’s medical history and potential contraindications before prescribing flibanserin.
Alternative Treatments: The Role of Testosterone Therapy
While flibanserin is the only FDA-approved medication for HSDD, testosterone therapy (TTh) has been used off-label for treating the condition. TTh involves administering testosterone via injections, topical applications, or pellets and is sometimes combined with estrogen therapy. However, unlike flibanserin, TTh lacks FDA approval for HSDD treatment, and further research is needed to establish its long-term safety and efficacy.
A Step Towards Empowerment
The expansion of flibanserin’s use to postmenopausal women holds the promise of empowering more women to take control of their sexual health. As Cindy Eckert aptly noted, this development is about “expanding access, expanding awareness, and expanding agency for women who have been overlooked for far too long.”
In conclusion, the FDA’s consideration of flibanserin for postmenopausal women highlights a growing recognition of the importance of addressing sexual wellness as a critical aspect of overall health. If approved, this expansion could pave the way for broader acceptance and treatment of HSDD, enhancing quality of life for countless women.
References
- FDA grants Priority Review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in postmenopausal women. Sprout Pharmaceuticals. July 24, 2025. Accessed July 24, 2025. https://www.prnewswire.com/news-releases/fda-grants-priority-review-for-addyi-flibanserin-paving-the-way-for-expanded-access-to-treat-low-sexual-desire-in-postmenopausal-women-302512883.html.
- Krewson C. Variations found in testosterone therapy for women with HSDD. Contemporary OB/GYN. May 7, 2024. Accessed July 24, 2025. https://www.contemporaryobgyn.net/view/variations-found-in-testosterone-therapy-for-women-with-hsdd.