FDA approves first postmenopausal libido treatment, Addyi

The FDA has expanded their approval of Sprout Pharmaceuticals’ Addyi (flibanserin), the first and only FDA-approved treatment for postmenopausal women ages 65 and younger with hypoactive sexual desire disorder (HSDD), also known as low libido, according to a news release published today. The FDA granted Addyi a Priority Review designation earlier this year. It was originally approved in 2015 for the treatment of HSDD in premenopausal women.

Hypoactive sexual desire disorder is characterized as a persistent lack of sexual interest. It is the most common form of sexual dysfunction in postmenopausal women, impacting approximately 40% - 55% of women during this time, caused by falling levels of estrogen, progesterone and testosterone.

Hormonal changes can also cause vaginal dryness and emotional shifts and fatigue, all of which can impact desire. This may lead to sadness or anxiety, which could cause relationship complications, especially if the sexual activity used to be much more frequent. Current treatments include testosterone; however, it is not currently approved by the FDA, and it carries potential side effects such as extra body hair, acne and voice changes.

“This milestone reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized,” Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, said in the news release. “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.”

Addyi is approved as a 100-mg tablet. The mechanism of action is currently not known.

"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," Rachel Rubin, M.D., urologist and sexual medicine specialist, said in the news release. "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 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."

Addyi should be taken at bedtime. Patients should avoid drinking more than three alcoholic beverages until the next day because of an increased risk of severe hypotension and syncope.

Addyi is not intended for women who experience low libido due to preexisting medical or psychiatric conditions, relationship conflict outside of symptoms or to mitigate the side effects of another medication, such as antidepressants, which can impact sex drive.

The original approval of Addyi was made using data from three 24-week randomized, double-blind, placebo-controlled trials in premenopausal women with acquired, generalized HSDD.

Adverse reactions occurred in at least 2% of patients; the most common were dizziness, somnolence, nausea, fatigue, insomnia and dry mouth.

"Menopause does not mark the end of a woman's sexuality but for too long, medicine has treated it that way," Mary Claire Haver, M.D., OB-GYN and leading menopause expert, said in the news release. "This FDA approval is a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire.”