FDA Approves Expanded Flibanserin Indication for Postmenopausal Women with Hypoactive Sexual Desire Disorder
Key Insights
The FDA approved expanded use of flibanserin 100 mg (Addyi) for hypoactive sexual desire disorder (search) in postmenopausal women younger than 65 years on December 15, 2025.
This represents the first FDA-approved pharmacologic treatment specifically for HSDD (search) in postmenopausal women, addressing a significant unmet medical need.
Flibanserin was originally approved in 2015 for premenopausal women and is a non-hormonal, centrally acting agent that modulates neurotransmitters (search) involved in sexual response.
The FDA has approved an expanded indication for flibanserin 100 mg (Addyi) to treat hypoactive sexual desire disorder (search) (HSDD (search)) in postmenopausal women younger than 65 years, Sprout Pharmaceuticals (search) announced on December 15, 2025. This landmark decision represents the first FDA approval specifically extending pharmacologic treatment options for postmenopausal women with HSDD, addressing a significant gap in women's sexual healthcare.
Addressing an Unmet Medical Need
HSDD (search) is characterized by a persistent lack of sexual interest or desire that causes distress and is not better explained by another medical or psychiatric condition. The disorder is considered the most common form of sexual dysfunction in women, with estimates suggesting that approximately 40% of women experience symptoms consistent with low sexual desire at some point in their lives. Despite its prevalence, treatment options have historically been limited, particularly for postmenopausal women.
"So many of my postmenopausal patients have carried the weight of frustrating low sexual desire with no FDA-approved option to turn to," said Rachel S. Rubin, MD, urologist and sexual medicine specialist. "Today's decision finally includes them. It's a critical acknowledgment that their pleasure, their wellbeing, and their quality-of-life matter—and that science-backed care should be available to every woman, at every stage of her life."
Regulatory Pathway and Priority Review
The approval follows the FDA's priority review designation for flibanserin in July 2025. Priority review is granted to drugs that "would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications," according to the FDA. The designation and subsequent approval reflect increasing regulatory attention to gaps in women's healthcare.
Flibanserin was initially approved by the FDA in 2015 for the treatment of HSDD (search) in premenopausal women. The medication is a nonhormonal, centrally acting agent that modulates key neurotransmitters (search) involved in sexual response. Since its original approval, its safety and efficacy profile has been evaluated in extensive clinical development programs, which Sprout described as the largest and most rigorous clinical trials conducted in women's sexual health.
Clinical Impact and Broader Implications
With the expanded US indication, Addyi is now approved for women younger than 65 years, making it the first and only FDA-approved pharmacologic therapy for HSDD (search) across this broader age range. International regulatory decisions preceded the US approval, with Health Canada authorizing the use of flibanserin in postmenopausal women in 2021.
"Menopause does not mark the end of a woman's sexuality but for too long, medicine has treated it that way," said Mary Claire Haver, MD, an obstetrician-gynecologist and menopause specialist. "This FDA approval is a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire. Expanding Addyi's approval is historic in validating women's experiences and ensuring that millions of women suffering have real choices when it comes to their sexual health."
Company Perspective and Market Access
Sprout Pharmaceuticals (search) stated that Addyi has been prescribed by more than 30,000 US healthcare professionals to date. The company emphasized that appropriate patient selection and counseling remain essential and that patients should consult with their physicians to determine whether treatment is appropriate.
"This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized," said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals (search). "Over the years, we've pushed for the science to speak louder than the stigma—and today's approval shows how far we've come. I want to congratulate the FDA for recognizing what millions of women have long deserved: equitable, science-backed care at every stage of life."