The U.S. Food and Drug Administration has approved Addyi® (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women under the age of 65, marking a first-of-its-kind decision for women’s sexual health.
The approval expands the use of Addyi, the first and only FDA-approved pill shown to treat low sexual desire in women, to include those who have gone through menopause. Until now, no FDA-approved treatment had been available for postmenopausal women experiencing HSDD, a condition described as common but widely undertreated.
Sprout Pharmaceuticals, the developer of Addyi, said the decision follows years of engagement with regulators and addresses a long-standing gap in care affecting millions of women. Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals, said, “This milestone reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized. 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 follows the FDA’s decision earlier this year to grant Priority Review status to the application. This designation is reserved for treatments that offer meaningful advances for serious unmet medical needs and shortens the agency’s review timeline.
Commenting on the wider impact of the decision, Eckert added: “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.”
Healthcare professionals specialising in sexual medicine also welcomed the move. Dr. Rachel Rubin, a urologist and sexual medicine specialist, said, “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.” She added that the approval offers long-awaited options for postmenopausal patients who previously had no FDA-approved treatment available.
Dr. Mary Claire Haver, an OB-GYN and menopause expert, said the decision challenges outdated assumptions in medicine. “Menopause does not mark the end of a woman’s sexuality but for too long, medicine has treated it that way,” she said.
Addyi was first approved by the FDA in 2015 for premenopausal women, supported by large-scale clinical trials. Its safety and effectiveness have since been recognised internationally, including expanded approval by Health Canada in 2021. With this decision, Addyi becomes the first and only FDA-approved treatment for HSDD in women under 65, representing a significant development in women’s healthcare.
