BOSTON (WHN) – The U.S. Food and Drug Administration (FDA) has expanded the approved use of Addyi (flibanserin) to include post-menopausal women experiencing low sexual desire. This decision, announced December 15, marks a significant shift in addressing hypoactive sexual desire disorder (HSDD) in an older demographic, a condition previously treated with the same medication only in pre-menopausal women.
Addyi functions by modulating neurotransmitter activity in the brain, specifically targeting dopamine, norepinephrine, and serotonin. The aim is to rebalance these chemical messengers, thereby stimulating signals associated with sexual desire while inhibiting those that suppress it.
The drug first received FDA approval in 2015. Its initial indication was for pre-menopausal women diagnosed with HSDD. The recent expansion now encompasses women under age 65 who have completed menopause—a period often characterized by declining hormone levels and subsequent changes in libido.
This expanded approval followed an additional review of data pertaining to post-menopausal women. The FDA’s requirement for this separate review, according to Cindy Eckert, CEO of Sprout Pharmaceuticals, highlights what she describes as a double standard and lingering stigma surrounding the medical treatment of sexual desire in women. Eckert noted that the data reviewed for this expansion was part of the company’s original submission, which included participants ranging in age from 18 to 80.
In an interview with TIME, Eckert detailed the protracted process leading to this approval, framing it as a broader cultural and scientific challenge for certain medications aimed at women’s health. She suggested the win is historic, signifying not only the scientific validation of a condition affecting millions but also a cultural acknowledgment of sexual health as integral to women’s overall wellness, longevity, and well-being. “And that their sex life doesn’t end at menopause,” Eckert stated.
She contrasted the landscape for women’s sexual health with that of men, recalling her experience building a male sexual health company when only one long-acting testosterone treatment was available. Now, she noted, there are 26 FDA-approved treatments for various forms of male sexual dysfunction. “I watched the big guns not do anything about the science,” Eckert said, interpreting this inaction as a reflection of how women’s sexual health was devalued compared to men’s.
Sprout Pharmaceuticals ultimately took on the challenge. Eckert anticipated the path would be difficult, stating, “And I should have anticipated that the first-ever drug for women’s sexual pleasure would not follow a straight line.” She emphasized the scientific basis for HSDD, a condition characterized in 1977, asserting that societal biases, rather than a lack of medical understanding, complicated its medical acceptance. The core issue, she posited, was a societal question of whether female pleasure matters.
The initial approval in 2015 for pre-menopausal women was based on clinical trials involving 13,000 women. This cohort size was reportedly three times larger than that of the trials conducted for Viagra at the time of its submission. While acknowledging the distinct nature of erectile dysfunction and HSDD, Eckert pointed out the disparity in approval timelines: six months for Viagra versus six years for Addyi.
“Addyi works on neurotransmitters in the brain,” Eckert explained. She suggested that for other central nervous system medications, age-based population separations are not typically as stringent. The FDA’s mandate for a separate review for post-menopausal women, using the same molecule and dosage, was seen by Eckert as a pattern in women’s health where societal conditioning influences the perceived importance of factors like sexual desire.
The drug’s introduction in 2015 brought discussions about potential risks, particularly when taken with alcohol. Studies indicated that side effects such as dizziness, sleepiness, and nausea occurred, leading to discontinuation in less than 2% of participants. The guidance suggests moderation: waiting a couple of hours after one or two drinks before bedtime dosing, or skipping the dose entirely if consuming more than three drinks.
Eckert stated that the focus on Addyi’s risks with alcohol, while present in virtually all coverage, should ultimately be a personal decision for each woman. She highlighted the benefits women might weigh: increased desire, interest, satisfying sexual events, and reduced stress related to their condition.
Globally, more women experience sexual dysfunction than men. The extension of Addyi’s approval to post-menopausal women is, in Eckert’s view, “long overdue.” She also described difficulties in securing funding for the product, noting that despite its higher prevalence than erectile dysfunction, venture capital firms were hesitant. She attributed this, in part, to the prevailing perspective on women’s health.
The process involved extensive dialogue, including a “six-hour, very public conversation with the FDA,” according to Eckert. She characterized some of the controversy as “manufactured,” stemming from societal attitudes towards women and sex.
Eckert highlighted the common societal response to menopause, which affects 50% of the population. Often, women are advised to “just relax, take a bubble bath; it’s just a transition period,” despite it being a biological phenomenon. This approach, she argued, reflects a deeper medical tendency to view women’s symptoms as psychosomatic or emotionally driven. She drew parallels to how women’s heart attack symptoms are sometimes dismissed or how pain medication is prescribed more slowly for women than for men.
This tendency, Eckert believes, stems from a societal view of women as primarily psychological and men as biological, which grants permission to dismiss women’s reported experiences. “We’ve created a culture of dismissal,” she asserted.
She views the Addyi approval as a “litmus test” for whether conversations around women’s health are fundamentally changing. The consideration of menopause, affecting half the population, should, she hopes, be taken more seriously. “Addyi is a case study for whether things have actually changed,” Eckert said.
Referring to the drug’s distinctive pink color, Eckert described it as “active defiance.” She interpreted dismissive remarks about “the little pink pill” as trivialization, which fueled her desire to confront the underlying conversation about the perceived unimportance of women’s loss of sexual desire. She recounted being criticized for wearing pink, with suggestions that people wouldn’t take her seriously. Her response was to embrace it: “I always loved pink, and never saw it as a sign of weakness. I see it as a strength to show up exactly as you are.”