FDA expands Addyi to postmenopausal women; Eckert calls it a historic win for women's health

The U.S. Food and Drug Administration on Dec. 15 approved Sprout Pharmaceuticals’ Addyi (flibanserin) to treat hypoactive sexual desire disorder in women who are past menopause, expanding the drug’s labeled population to include postmenopausal women under 65. The decision places Addyi in the rare category of medicines intended to address sexual desire in women, a population for which few targeted therapies exist. The approval follows years of advocacy from the company and its supporters who have argued that women’s sexual health has too often been sidelined in medical research.

Addyi works by modulating neurochemistry in the brain—balancing dopamine, norepinephrine and serotonin to enhance desire signaling while dampening inhibitory pathways. The drug has been approved since 2015 to treat hypoactive sexual desire disorder in premenopausal women. For the postmenopausal label expansion, the FDA required an additional review of data Sprout had already provided; new studies were not conducted. The company’s data and the accompanying safety profile were reviewed as part of the agency’s broader assessment of the age-related label change. The safety considerations remain focused on managing effects such as dizziness, sleepiness and nausea, and the agency has continued to emphasize that alcohol interactions can influence risks. See the correction note at the end of this article for further detail on the approval process.

In discussing what the decision means for women’s health, Sprout founder and CEO Cindy Eckert framed it as a milestone that extends beyond a single drug. In a TIME interview, she described the postmenopausal approval as “an historic first in women’s health.” She said it signals scientific recognition of a medical condition that affects millions and a cultural acknowledgment that sexual health is part of women’s overall wellness and longevity. “I might not have fully processed yet how big this win is,” she said, adding that the approval shows that women’s sexual health deserves serious consideration rather than stigma.

The expansion to postmenopausal women is notable because hormone levels decline after menopause, often changing libido. The label now covers postmenopausal individuals under 65, reflecting the FDA’s careful review of how Addyi performs in this broader population. Sprout’s chief explained that the company sought to widen access after noting a lack of approved options for women’s sexual health and after facing years in which no medicines comparable to male erectile-dysfunction therapies existed for women. Eckert highlighted what she described as a historical bias: medicines for male sexual health have long had extensive investment and approval pathways, while therapeutic options for women were slower to develop due to cultural and scientific misperceptions about female desire.

The journey to this point included a six-year path to approval for postmenopausal use, following Addyi’s original 2015 approval for premenopausal women with HSDD. Sprout cites data from clinical trials involving roughly 13,000 women—nearly three times the size of the trials for Viagra at the time of its approval—as evidence of the drug’s efficacy and safety in the broader population. Eckert argues that a more extensive, diverse set of trials for men’s products did not translate into the same pace for women’s therapies, a discrepancy she says reflects enduring gender bias within the medical community and venture-capital funding ecosystems.

The company has faced challenges beyond clinical data. Eckert described persistent underfunding from traditional investors and a need to push back against “manufactured controversy” during regulatory discussions, including a lengthy, publicly scrutinized dialogue with the FDA. She recounts how the science-driven approach—rather than cultural assumptions—ultimately prevailed, even as some skeptics argued about legitimizing female sexual desire as a medical matter. The expanded approval is not only a milestone for Addyi but a potential signal about future research and development in women’s health.

Safety considerations associated with Addyi remain central. Early discussions around the medication highlighted potential interactions with alcohol, which can heighten dizziness or sleepiness. Company guidance suggests timing considerations if alcohol is consumed; in general, one or two drinks may require waiting a few hours before taking the dose, and more than three drinks should lead to skipping the nightly dose. Fewer than 2% of participants discontinued Addyi due to adverse events in prior trials. Eckert framed these risks in terms of informed choice for individual patients, emphasizing that women should weigh potential benefits—such as increased desire, improved sexual events, and reduced stress about the condition—against the known risks.

Experts say the new approval could influence how regulators and the medical community view other women’s health products. Eckert argues that the decision serves as a litmus test for whether the healthcare system will take menopausal changes seriously and address sexual health as a meaningful aspect of long-term wellness. The “pink pill” label has also become a symbol of the struggle to normalize discussions of female sexuality in medical research and treatment.

The Dec. 16 correction note clarifies that the FDA did not require new Postmenopausal studies to approve Addyi; rather, the agency conducted an additional review of existing evidence from a broader age range that had already been submitted. The correction underscores the importance of precise language in describing how regulatory decisions are made and how data from earlier trials support expanded indications.

In sum, the FDA’s decision to extend Addyi’s use to postmenopausal women under 65 marks a notable shift in how women’s sexual health is evaluated and treated. It aligns regulatory scrutiny with evolving scientific understanding of HSDD across a broader age spectrum and reinforces the ongoing discussion about equity in women’s health research and drug development.