The U.S. Food and Drug Administration has approved Addyi (flibanserin) for the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women under 65. The decision expands the drug’s original 2015 approval, which was limited to premenopausal women.
Sprout Pharmaceuticals, which manufactures Addyi, received Priority Review designation for the expanded indication earlier this year. Health Canada approved the drug for postmenopausal women in 2021.
HSDD is characterized by persistent low sexual desire that causes distress. According to the Mayo Clinic, the condition affects an estimated 40% of women. Addyi is a non-hormonal medication that works on neurotransmitters affecting sexual response and is currently prescribed by over 30,000 U.S. healthcare professionals, according to the company.
“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.”
Dr. Rachel Rubin, a urologist and sexual medicine specialist, said: “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 specialist, added: “This FDA approval is a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire.”
With this expanded approval, Addyi becomes the only FDA-approved oral treatment for HSDD in women under 65, regardless of menopausal status.
