FDA expands Addyi approval to include postmenopausal women, closing a long-standing gap in sexual health care
First and only FDA-approved pill for treatment of HSDD in both premenopausal and postmenopausal women.
A decade after becoming the first FDA-approved drug for female sexual desire, Addyi® (flibanserin) has received expanded approval in the United States to include postmenopausal women — a regulatory decision that closes a long-standing gap in treatment options for Hypoactive Sexual Desire Disorder (HSDD).
The approval, announced by Sprout Pharmaceuticals, allows Addyi to be prescribed to women under the age of 65 who have gone through menopause. Until now, the drug’s U.S. indication had been limited to premenopausal women, despite persistent reports of unmet need among postmenopausal patients.
HSDD is defined as persistently low sexual desire that causes marked distress or interpersonal difficulty and is not better explained by another medical or psychiatric condition, relationship factors, or medication effects. While it is widely recognised by clinicians, it remains significantly underdiagnosed and undertreated.
A milestone years in the making
Addyi was first approved by the FDA in 2015 after a highly public and controversial review process that involved it being tested on 23 men and only two women. That drew attention to how women’s sexual health is evaluated, studied, and prioritised. The drug — originally investigated as an antidepressant — became a flashpoint for debates about gender bias in drug development and regulatory standards, particularly when compared with the number of approved treatments for male sexual dysfunction such as viagra.
“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.”
The expanded indication follows the FDA’s decision earlier this year to grant Addyi Priority Review, a designation reserved for therapies that address serious unmet medical needs. While HSDD is not life-threatening, advocates have long argued that its impact on quality of life, relationships, and mental wellbeing warrants greater regulatory attention.
What changes — and who it affects
With the updated approval, Addyi becomes the first and only FDA-approved pill indicated for the treatment of HSDD in both premenopausal and postmenopausal women under 65.
Clinicians specialising in sexual medicine and menopause care have welcomed the decision, particularly for patients who previously fell outside the approved label.
“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, a 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.”
Dr. Mary Claire Haver, an OB-GYN and menopause expert, framed the approval as a corrective to how medicine has historically treated women after menopause.
“Menopause does not mark the end of a woman’s sexuality but for too long, medicine has treated it that way,” she said.
“This FDA approval is a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire.”
Sprout Pharmaceuticals says the expanded approval is supported by what it describes as the largest and most rigorous clinical trials conducted in women’s sexual health, building on Addyi’s established safety and efficacy profile. Outside the U.S., Health Canada approved Addyi for postmenopausal women in 2021, a regulatory move that helped pave the way for the FDA’s latest decision.
The approval is a positive signal of women’s health conditions being evaluated on quality of life rather than just mortality, and recognition of unmet need.
Fantastic coverage of this approval. The testing disparity here is staggering, 23 men versus 2 women for a drug targeting female sexual desire basically encapsulates decades of pharma prioritizing speed and convenience over appropriate cohort selection. I've seen similar patterns in cardiovascular trials where womens' symptom profiles differ substantially but get lumped into male-dominated datasets. The fact it took a decade plus Canada's earlier move to expand this indicaton says alot about how regulatory frameworks lag behind clinical need.