FDA Expands Addyi to Postmenopausal Women Under 65

The FDA on December 15 approved Sprout Pharmaceuticals Addyi, with the generic name flibanserin, to treat hypoactive sexual desire disorder in postmenopausal women under 65. The approval expands the drug's previously age-limited indication, which had applied to premenopausal women since 2015. Regulators said the decision relies on existing data from previous trials and required an additional review to ensure safety and efficacy in the newer age group. The change aims to address the drop in libido and related distress among women who reach menopause while maintaining a focus on sexual health as part of overall well being.

Addyi works by modulating several brain neurotransmitters, including dopamine, norepinephrine, and serotonin, to boost sexual desire signals and dampen inhibitory pathways. The same molecule and dosage approved for premenopausal women are now considered for a different population, with the FDA and Sprout noting that similarities in mechanism across age groups do not automatically translate into identical outcomes. The drug’s approval in 2015 for premenopausal women came after trials involving about 13,000 participants, a scale that was cited by Sprout as being larger than contemporaneous studies for other sexual dysfunction medications. The current move to extend approval took six years, in contrast to the roughly six months often seen in some male sexual health approvals, a contrast Sprout’s leadership has framed as a reflection of the lag in recognizing women’s health needs.

The FDA said no new clinical trials were required to add postmenopausal women under 65 to Addyi’s label. Instead, regulators reviewed Sprout’s existing data for safety and efficacy in the older population to determine whether the benefits outweigh the risks in this larger group. Critics and advocates alike have long debated how medical evidence is gathered and interpreted for women, particularly on issues tied to sexual health. Sprout chief executive officer Cindy Eckert has described the expanded review as addressing a historical bias that has sidelined women’s sexual health in drug development, even as some commentators noted that social considerations can influence risk framing and labeling in medicine.

Safety remains a central factor in Addyi’s use. Earlier labeling highlighted potential dizziness, sleepiness, and nausea, with less than 2 percent of participants discontinue the drug due to adverse effects. Among the danger signals often discussed with Addyi is interaction with alcohol; the label has long advised users to limit or avoid alcohol and to administer the drug at bedtime with caution. Eckert has argued that women should weigh the benefits—greater desire, more fulfilling sexual events, and reduced distress about libido—against the risks themselves, emphasizing patient autonomy in decision making.

Beyond the clinical and regulatory details, Eckert has described the path to Addyi as a struggle to secure funding and recognition for women’s health products. She has recounted six hours of direct, sometimes contentious dialogue with the FDA and said that venture capital funding was harder to secure for a women’s health product with a higher prevalence of sexual dysfunction in women than erectile dysfunction in men. Her account points to broader questions about how the medical community and investors value medicines that address female sexuality and menopause, a topic she says has long been stigmatized rather than treated as a legitimate medical concern.

The broader implications extend beyond Addyi itself. Eckert argues that the approval could serve as a barometer for how the industry approaches women’s health products, especially those addressing menopause and sexual wellness. She has framed the pink pill as a deliberate stance against dismissiveness toward female sexual health, describing pink as a symbol of defiance rather than a sign of weakness. The evolving conversation around Addyi, she says, may indicate whether society will treat women’s sexual health as a core aspect of wellness rather than a peripheral concern.

The episode also raises questions about how new indications for existing drugs are treated and how data from earlier trials are leveraged as populations shift. The correction accompanying the original report makes clear that new studies were not conducted to extend Addyi’s approval to postmenopausal women; instead, regulators relied on previously submitted data and conducted an additional review to confirm safety and efficacy for the expanded population. If the approach proves durable, the postmenopausal extension of Addyi could act as a test case for future efforts to expand existing therapies to additional demographic groups while maintaining scientific rigor and patient safety.

The development underscores a broader shift in how health care systems view menopause as a physiological state worthy of targeted therapies, rather than a passive transition. As more drugs target female sexual health and menopause-related challenges, policymakers, clinicians, and patients will be watching to see whether the momentum translates into more research, broader access, and a more balanced view of women’s health across ages.