The U.S. Food and Drug Administration (FDA) has approved the first daily pill, Addyi, designed to treat acquired generalized hypoactive disorder (AGHD) – low sexual desire – in women who have gone through menopause. This marks a significant shift in how women’s sexual health is addressed, finally providing a targeted treatment option where none previously existed.
Why This Matters: A Long-Overlooked Issue
For decades, female sexual dysfunction has been under-researched and under-treated compared to male sexual health. The lack of FDA-approved options has left many women with limited recourse, often attributing declining libido solely to age or hormonal changes without exploring potential pharmacological interventions. This approval acknowledges that low sexual desire in postmenopausal women can be a distinct medical condition deserving of treatment.
How Addyi Works: Targeting Brain Chemistry
Addyi is a non-hormonal medication that manipulates brain neurotransmitters to boost sexual desire. It increases levels of dopamine and norepinephrine – chemicals linked to reward and arousal – while decreasing serotonin, which can inhibit sexual response. This mimics the natural neurological processes that occur when a person experiences sexual interest, but re-establishes those pathways in women whose libido has diminished.
According to Dr. Nanette Santoro of the University of Colorado School of Medicine, the underlying mechanisms aren’t fully understood, but Addyi appears to “preserve that pathway” when natural stimulation falters.
The Role of Menopause: Beyond Hormonal Decline
While estrogen and progesterone levels drop during menopause, experts emphasize that hormonal imbalances alone don’t fully explain decreased libido. Dr. Santoro points out that simply replacing hormones doesn’t necessarily restore sexual desire. Societal attitudes, psychological factors, and even physical discomfort (pain during intercourse, urinary issues) can all contribute. Dr. JoAnn Manson of Harvard Medical School suggests that if the root cause isn’t primarily physiological, Addyi may offer a viable solution.
Clinical Trial Results: Modest But Meaningful
Clinical trials showed Addyi was effective, though improvements were relatively small – comparable to results seen in younger women with the same condition. Approximately 40% of women experience low libido, and this approval extends treatment options to postmenopausal individuals who previously had no FDA-approved alternatives.
Risks and Precautions: A Serious Consideration
Addyi carries risks, including dangerously low blood pressure and fainting. Patients with liver problems, those consuming alcohol near bedtime, or taking certain medications (antifungals, antivirals, blood pressure drugs, HIV treatments) are at higher risk. Sprout Pharmaceuticals advises waiting at least two hours after drinking alcohol before taking Addyi, or avoiding alcohol altogether after dosage.
Overcoming Barriers to Treatment
Historically, many doctors have been hesitant to discuss low libido with postmenopausal women due to the lack of available treatments and insufficient training in this area. The approval of Addyi may encourage more open conversations and proactive management of women’s sexual health.
Dr. JoAnn Pinkerton of the University of Virginia notes that this approval is crucial because “Women now have a way to improve their sexual health.” The Menopause Society provides an online tool to locate healthcare providers experienced in treating postmenopausal women.
Cost and Availability
Addyi costs $298 per month retail, but patients with insurance may access it for $40 annually through the drugmaker’s copay program. Direct-to-consumer options through PHILRx offer monthly subscriptions for $149 or quarterly bundles for $297.
The FDA’s decision to extend Addyi’s approval to women under 65 represents a significant step forward in recognizing and addressing the often-overlooked issue of low sexual desire in postmenopausal women, providing a new avenue for improving their quality of life.
