Historic FDA Approval Expands Libido Pill Access for Postmenopausal Women
- 16 dic
- 2 Min. de lectura
The U.S. Food and Drug Administration (FDA) has announced a significant development in women's health, expanding the approval of flibanserin (Addyi) 100 mg for treating Hypoactive Sexual Desire Disorder (HSDD) in women younger than 65 years. This decision marks a "historic first" as it extends the indication beyond premenopausal women to include postmenopausal women in this age group, making flibanserin the first FDA-approved pharmacologic treatment for HSDD in this population.
Flibanserin, an once-daily pill marketed by Sprout Pharmaceuticals, was initially approved by the FDA in 2015 for premenopausal women struggling with HSDD. The current expanded approval, which came after a Priority Review designation earlier in 2025, allows the drug to be prescribed to women younger than 65 regardless of their menopausal status.
HSDD is characterized by a persistently low sexual desire that causes personal distress, and it is widely considered to be common but underdiagnosed and undertreated. The condition impacts an estimated 40% of women, according to the Mayo Clinic.
Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, celebrated the decision, stating that the milestone "reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized". She added that the expanded indication closes a gap in care and acknowledges the importance of providing "equitable, science-backed care at every stage of life".
Sexual medicine specialists echoed this sentiment, emphasizing the overdue recognition for postmenopausal women. Dr. Rachel Rubin, a urologist and sexual medicine specialist, noted that many of her postmenopausal patients had previously lacked an FDA-approved option for frustrating low sexual desire, stressing that the decision confirms "their pleasure, their wellbeing, and their quality of life matter". Dr. Mary Claire Haver, an obstetrician-gynecologist, called the approval a "long-overdue recognition" that acknowledges menopause should not signify the end of a woman's sexuality.
The expanded approval is supported by what Sprout Pharmaceuticals describes as the most rigorous clinical trials conducted in women’s sexual health. International precedent was already set when Health Canada approved flibanserin for use in postmenopausal women in 2021.
However, the drug's use still carries important safety information. Flibanserin, which acts on brain chemicals affecting mood and appetite, includes a Boxed Warning—the FDA's most serious type—cautions patients about the risks of combining it with alcohol. Consuming alcohol close to the time of dosing can cause dangerously low blood pressure and fainting. Severe low blood pressure and fainting are also increased if the drug is taken with certain medicines or if the patient has liver problems. Common side effects of Addyi include dizziness, nausea, and sleepiness. Patients are warned against drinking alcohol close to the time of taking their dose and should not take Addyi if they have liver problems or are taking certain medicines.
Despite the safety warnings and historically limited sales, this approval is seen as a major shift toward improving access to treatment for HSDD, a condition that remains profoundly undertreated.
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Keywords: FDA Approval for Postmenopausal Women
FDA Approval for Postmenopausal Women
