madman
Super Moderator
* With the approval today, flibanserin becomes the first and only treatment of its kind for women younger than 65 years, Sprout Pharmaceuticals noted.
www.urologytimes.com
On December 15, 2025, the FDA approved an expanded indication for flibanserin 100 mg (Addyi) for hypoactive sexual desire disorder (HSDD) in postmenopausal women younger than 65 years, Sprout Pharmaceuticals announced in a news release.1
Flibanserin was previously approved by the FDA in 2015 to treat HSDD in certain premenopausal women.2 Health Canada has also approved expanded use of the non-hormonal medication in women who have gone through menopause.
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 Rachel S. Rubin, MD, urologist and sexual medicine specialist, in the news release.1 "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."
This approval follows the FDA’s priority review designation for flibanserin in July 2025. Priority review is granted to drugs that “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” according to the FDA.3
With the approval today, flibanserin becomes the first and only treatment of its kind for women younger than 65 years, Sprout Pharmaceuticals noted.
"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, in the news release.1 "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."
Key Takeaways
- Flibanserin (Addyi) is now approved for treating HSDD in postmenopausal women, expanding its previous indication for premenopausal women.
- The FDA's priority review designation for flibanserin underscores its potential to significantly improve treatment safety and effectiveness.
- This approval marks a pivotal moment in women's sexual health, emphasizing the need for equitable, science-backed care across all life stages.
- Flibanserin remains the only treatment of its kind for women under 65, reflecting a decade of advocacy and scientific progress.
FDA approves flibanserin for hypoactive sexual desire disorder in postmenopausal women | Urology Times
With this approval, flibanserin becomes the first and only treatment of its kind for women younger than 65 years.
On December 15, 2025, the FDA approved an expanded indication for flibanserin 100 mg (Addyi) for hypoactive sexual desire disorder (HSDD) in postmenopausal women younger than 65 years, Sprout Pharmaceuticals announced in a news release.1
Flibanserin was previously approved by the FDA in 2015 to treat HSDD in certain premenopausal women.2 Health Canada has also approved expanded use of the non-hormonal medication in women who have gone through menopause.
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 Rachel S. Rubin, MD, urologist and sexual medicine specialist, in the news release.1 "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."
This approval follows the FDA’s priority review designation for flibanserin in July 2025. Priority review is granted to drugs that “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” according to the FDA.3
With the approval today, flibanserin becomes the first and only treatment of its kind for women younger than 65 years, Sprout Pharmaceuticals noted.
"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, in the news release.1 "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."
