The availability of the “little pink pill,” known as Addyi, has been extended to more women following the FDA’s recent approval for postmenopausal women. This marks the first medication aimed at low sexual desire for women both before and after menopause under the age of 65.
Addyi is intended for women diagnosed with hypoactive sexual desire disorder (HSDD), rather than all women experiencing low desire. This approval broadens access to a significant number of women. “This is a significant step forward in women’s sexual health,” says Jessica Shepherd, MD, an obstetrician-gynecologist.
Understanding Addyi and Its Use
Addyi, or flibanserin, is a prescription drug specifically designed to treat HSDD, a condition characterized by a persistently low sex drive that causes distress. According to the International Society for Sexual Medicine (ISSM), approximately one in ten women suffer from HSDD, making it a prevalent sexual health issue.
The treatment regimen is straightforward, with the pill taken once daily at bedtime. “Women who opt for this treatment may see considerable improvements in their intimate relationships,” notes Dr. Shepherd.
However, Addyi may not be effective for everyone. “Libido is influenced by multiple factors,” explains Lauren Streicher, MD, a clinical professor at Northwestern University Feinberg School of Medicine. “Flibanserin primarily targets serotonin levels in the brain, but other factors also affect libido, so it’s not a guaranteed solution.”
Originally approved in 2015 for premenopausal women, the data from that time has now been used to extend approval to postmenopausal women. The clinical trials included participants aged 18 to 80, and the FDA’s recent decision is based on this initial data.
Clinical Findings and FDA Approval
A meta-analysis of trials conducted from 2015 to 2024 demonstrated that Addyi was more effective than a placebo in enhancing sexual desire scores, as recorded in electronic diaries. Importantly, more women with HSDD reported a “meaningful benefit” from Addyi compared to those on a placebo.
The FDA’s Priority Review designation, granted earlier this year, expedited the approval process. This makes Addyi the first and only treatment of its kind available for postmenopausal women.
Implications for Women’s Health
Despite numerous options available for men’s low libido, Addyi is one of the few FDA-approved treatments for women. “It’s crucial to empower women in managing their sexual health,” says Dr. Shepherd. Women’s health expert, Jennifer Wider, MD, concurs, stating, “This is an important advancement, providing a viable option for menopausal women.”
Addyi is particularly beneficial for postmenopausal women who experience hormonal changes during menopause. “The decline in testosterone during menopause, which affects libido, is often overlooked,” Dr. Shepherd points out. “Addyi offers a way to boost sexual desire and enhance libido in postmenopausal women, apart from hormone replacement therapy.”
Considering Addyi as a Treatment Option
Addyi should be viewed as “another tool in the toolbox,” rather than a miracle solution, suggests Dr. Streicher. “While it won’t solve all sexual health and libido issues for postmenopausal women, it’s a safe option.”
For those considering Addyi, discussing it with a healthcare provider is essential. They can guide you through the benefits and drawbacks, helping you determine if it’s the right choice for your needs.