FDA Expands Approval of Flibanserin for Hypoactive Sexual Desire Disorder to Women Younger Than 65 Years

The US FDA has approved 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 indication beyond premenopausal women and makes flibanserin the first FDA-approved pharmacologic treatment for HSDD in postmenopausal women in this age group.

Flibanserin was initially approved by the FDA in 2015 for premenopausal women with HSDD. The current action follows a Priority Review designation granted earlier in 2025, a pathway reserved for therapies that may offer meaningful improvements for serious conditions with unmet medical needs.

“This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized,” Cindy Eckert, founder and chief executive officer of Sprout Pharmaceuticals, said in the press release. “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.”

HSDD is characterized by persistently low sexual desire that causes personal distress and is considered common but underdiagnosed and undertreated, according to the company. With the expanded indication, flibanserin may now be prescribed to women younger than 65 years regardless of menopausal status.

“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 in the press release.

Clinicians specializing in sexual medicine and menopause also commented on the decision.

“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,” Rachel Rubin, MD, a urologist and sexual medicine specialist, said in the press release. “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.”

Mary Claire Haver, MD, an obstetrician-gynecologist and menopause specialist, added: “Menopause does not mark the end of a woman's sexuality but for too long, medicine has treated it that way. 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.”

According to the release, flibanserin’s expanded approval is supported by what the company described as the largest and most rigorous clinical trials conducted in women’s sexual health. International regulatory precedent was cited, noting that Health Canada approved flibanserin for use in postmenopausal women in 2021.

With the new indication, flibanserin is now approved for women younger than 65 years and remains the only FDA-approved treatment for HSDD in this population.

Reference: Historic First in Women's Sexual Health: FDA Grants Approval for Addyi® (flibanserin) in Postmenopausal Women. News release. Sprout Pharmaceuticals. December 15, 2025. Accessed December 15, 2025. https://www.prnewswire.com/news-releases/historic-first-in-womens-sexual-health-fda-grants-approval-for-addyi-flibanserin-in-postmenopausal-women-302642397.html