FDA expands Addyi to treat low sexual desire in postmenopausal women under 65

The U.S. Food and Drug Administration on Dec. 15 expanded the label for Sprout Pharmaceuticals' Addyi (flibanserin) to treat hypoactive sexual desire disorder in women who are postmenopausal and under 65, broadening the population eligible for the pill.

Addyi works by modulating neurotransmitters in the brain, including dopamine, norepinephrine and serotonin, to stimulate sexual desire signals while dampening inhibitory signals. The drug was first approved in 2015 to treat HSDD in premenopausal women; the new approval applies the same molecule and dosage to a different patient group.

The U.S. Food and Drug Administration indicated that it required an additional review of data on postmenopausal women to ensure safety and efficacy for the broader age group, but no new clinical studies were mandated. The agency said the existing data supported expanding Addyi’s labeling to include postmenopausal women under 65 who experience HSDD, a population facing changes in hormone levels that can affect libido.

Sprout Chief Executive Cindy Eckert framed the decision as a milestone in women’s health. In remarks tied to a Time interview, she described the approval as "an historic first in women’s health" and said it represents scientific recognition of a medical condition that affects millions of women and a cultural acknowledgment that sexual health is part of overall wellness. She added that society has long treated women’s sexual health as less central than men’s and argued that women’s desire matters as part of longevity and well-being.

The expansion comes after a long road for Addyi, which requires careful balancing of benefits and risks. Eckert noted that the premenopausal approval drew on trials involving about 13,000 women, a number she said was larger than the scale of erectile dysfunction trials used for Viagra at the time of its approval. She contrasted the six-year path to Addyi’s approval with Viagra’s roughly six-month timeline, saying that gender bias influenced the pace of development and regulatory review. Eckert has described the pink color and branding as intentional, a form of defiance aimed at reframing how society discusses women’s sexual health rather than signaling weakness.

In discussing safety, Eckert and other clinicians have highlighted the potential for dizziness, sleepiness and nausea, particularly when alcohol is involved. Earlier labeling advised caution with alcohol use; some women experience these side effects and fewer than 2% discontinue Addyi because of them. The guidance historically urged patients to avoid alcohol on dosing nights, or to skip the dose if multiple drinks are consumed.

Outside the pharmacology and regulatory dimensions, supporters view the approval as a barometer for how the medical system treats menopausal changes. Eckert argues that menopause is a biological phenomenon that warrants medical attention rather than benign neglect, and she contends that a market exist for more female-focused treatments. Advocates say expanding Addyi’s use signals a shift toward recognizing sexual health as a standard component of women’s health care, rather than a topic confined to stigma or discomfort.

The broader implications for women’s health products are significant for industry observers. If the postmenopausal expansion is viewed as a success, it could influence how regulators assess efficacy and safety across broader age ranges and motivate researchers and investors to pursue therapies addressing female sexual health, fertility, and menopause-related changes. Eckert described the decision as a potential turning point that could encourage more products aimed at conditions that affect half the population during midlife and beyond.

Correction, Dec. 16: The original version of this story mischaracterized how the drug was approved for postmenopausal women. The FDA required an additional review of data Sprout had already provided; new studies were not conducted.