US FDA approves libido-boosting pill for postmenopausal women

The US FDA has approved Addyi, a pill that boosts female libido, for women postmenopause. Addyi (flibanserin 100 mg) is “the first and only” FDA-approved pill clinically proven to treat low sex drive in women. 

The pill from Sprout Pharmaceuticals treats Hypoactive Sexual Desire Disorder (HSDD), and can now be used by women over the age of 65, as per the US health officials’ approval. 

“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 health care,” says Cindy Eckert, founder and CEO of Sprout Pharmaceuticals.

The expanded approval follows the FDA’s Priority Review designation announced earlier this year. The status is reserved for drugs that represent meaningful improvements in the treatment of serious unmet medical needs. 

Speaking about the recent approval, the pharmaceutical company CEO says: “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.”

Clinically- and FDA-backed 

Sprout Pharmaceuticals claims that Addyi is supported by the “largest and most rigorous clinical trials ever conducted in women’s sexual health.” 

The FDA’s approval of Addyi marks a milestone for women’s health. Addyi first received FDA approval in 2015 for premenopausal women. Its safety and efficacy profile has been reaffirmed globally, with Health Canada approving it for expanded use in postmenopausal women in 2021.

 “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,” says Dr. Rachel Rubin, urologist and sexual medicine specialist.

“It’s a critical acknowledgment that their pleasure, their well-being, and their quality of life matter — and that science-backed care should be available to every woman, at every stage of her life.”

Menopause market moves

Menopausal care is booming in the personal care industry, with an increased focus on ingredient development and a rising awareness of this audience’s needs.

Personal Care Insights recently spoke with Dr. Iona Weir, founder and CEO of Myregyna, to discuss its over-the-counter solutions that relieve symptoms of vaginal atrophy in postmenopausal women. 

We also explored how the expanding menopause market is driving a concurrent rise in “menopause-washing” with Weir.