FDA Expands approval of sexual desire drug Flibanserin to Postmenopausal Women
The FDA has expanded the approval of flibanserin (Addyi), a medication for low sexual desire in women, to include certain postmenopausal women. The decision, announced by Sprout Pharmaceuticals, marks a significant step forward in women’s sexual health by broadening treatment options beyond premenopausal women.
This long-awaited decision closes a gap in care for millions of postmenopausal women experiencing frustrating low sexual desire and marks a historic first approval for the FDA.
"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. "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."
The expanded approval of Addyi follows the FDA's Priority Review designation announced earlier this year, a status reserved for drugs that represent meaningful improvements in the treatment for serious unmet medical needs. This designation underscores the Agency's increasing commitment to addressing long-standing gaps in women's health and ensuring timely access to evidence-based 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 treat women with HSDD celebrated the Agency's decision, including those who witnessed the original milestone a decade ago.
"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," said Dr. Rachel Rubin, urologist and sexual medicine specialist. "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."
"Menopause does not mark the end of a woman's sexuality but for too long, medicine has treated it that way," said Dr. Mary Claire Haver, OB-GYN and leading menopause expert. "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."
Supported by the largest and most rigorous clinical trials ever conducted in women's sexual health, Addyi first received FDA approval in 2015 for premenopausal women. Its established safety and efficacy profile has been reaffirmed globally: in 2021, Health Canada approved Addyi for expanded use in postmenopausal women, paving the way for today's milestone in the United States.
With this expanded approval, Addyi becomes the first and only treatment of its kind for women <65 years marking a defining moment in the pursuit of sexual-health equity and reinforcing the essential truth that women deserve comprehensive, evidence-based care throughout their entire lives.
