FDA approves expanded use of flibanserin for hypoactive sexual desire disorder in women

The FDA has approved Addyi (flibanserin 100 mg) for the treatment of hypoactive sexual desire disorder (HSDD) in women younger than 65 years, according to an announcement from Sprout Pharmaceuticals. The decision expands the drug’s original indication and represents the first FDA approval specifically extending pharmacologic treatment options for postmenopausal women with HSDD.¹

HSDD 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. It 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.

“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 chief executive officer of Sprout Pharmaceuticals. “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.”

Addyi was initially approved by the FDA in 2015 for the treatment of HSDD in premenopausal women. The medication is a nonhormonal, centrally acting agent that modulates key neurotransmitters 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.

The current approval follows the FDA’s decision earlier this year to grant Priority Review status to the expanded indication. Priority Review is reserved for therapies that may provide significant improvements in the treatment of serious conditions or address unmet medical needs. According to the company, the designation and subsequent approval reflect increasing regulatory attention to gaps in women’s health care.

“This is a major shift in expanding awareness and access to treatment for HSDD—a condition that is both common and profoundly undertreated—and we’re grateful that the FDA has acknowledged the importance of closing this gap in women’s sexual healthcare,” Eckert added.

Clinicians who specialize in sexual medicine and menopause care have described the expanded approval as an important step for patients who previously lacked FDA-approved treatment options. Rachel Rubin, MD, a urologist and sexual medicine specialist, highlighted the clinical implications for postmenopausal patients.

“I was in the room a decade ago when Addyi became the historic first for women’s sexual health, and I have been waiting for this moment ever since,” Rubin said. “So many of my postmenopausal patients have carried the weight of frustrating low sexual desire with no FDA-approved option to turn to. 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.”

International regulatory decisions preceded the US approval. In 2021, Health Canada authorized the use of flibanserin in postmenopausal women, a move that Sprout cited as an important step toward the current FDA action. 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 across this broader age range.

Sprout Pharmaceuticals stated that Addyi has been prescribed by more than 30,000 US health care 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.

Mary Claire Haver, MD, an obstetrician-gynecologist and menopause specialist, also emphasized the broader clinical context of the approval.

“Menopause does not mark the end of a woman’s sexuality but for too long, medicine has treated it that way,” Haver said. “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.”

Reference

1. Sprout Pharmaceuticals. Historic First in Women’s Sexual Health: FDA Grants Approval for Addyi® (flibanserin) in Postmenopausal Women. PR Newswire. December 15, 2025. Accessed December 15, 2025.