U.S. health officials have broadened the approval of Addyi, a medication designed to enhance female libido, allowing its use for women over the age of 65 who have experienced menopause. The announcement, made by the Food and Drug Administration (FDA) on October 23, 2023, marks a significant shift in the drug’s application, which was initially approved in 2015 for premenopausal women suffering from low sexual desire linked to emotional stress.
Addyi, marketed by Sprout Pharmaceuticals, was anticipated to become a key player in women’s health. However, it has faced challenges due to side effects such as dizziness and nausea. The drug carries a serious warning about the potential dangers of consuming alcohol while taking it, which can lead to dangerously low blood pressure and fainting. This boxed warning is the most stringent classification issued by the FDA.
The approval of Addyi for older women comes as research into female sexual health continues to evolve. Cindy Eckert, CEO of Sprout, emphasized that this decision reflects a decade-long effort to reshape the understanding and prioritization of women’s sexual health. She expressed optimism about the expanded use of the drug, stating that it could offer an option for many women who may have felt overlooked in discussions about sexual wellness.
The condition known as hypoactive sexual desire disorder has been recognized since the 1990s and is estimated to affect a significant number of women in the United States. This condition can arise from various factors, particularly after menopause, when hormonal changes can impact libido. While many women may experience a decline in sexual desire, diagnosing the condition can be complicated. Doctors often need to rule out other potential causes, including relationship issues, medical conditions, and mental health disorders.
Despite the potential benefits of Addyi, its initial reception was mixed, as the FDA rejected it twice before its eventual approval. Critics have raised concerns about the drug’s modest effectiveness and side effects. The lobbying efforts by Sprout and advocacy groups like Even the Score framed the conversation around female libido as a matter of women’s rights, pushing for more options in sexual health.
In recent years, the FDA has also approved another treatment for low female libido, an on-demand injection that operates through different neurological pathways. This development underscores the growing attention being paid to women’s sexual health, a field that has historically lagged behind research and treatment options available for men.
The expansion of Addyi’s approval signifies a shift in the medical community’s approach to female sexual health, highlighting the need for more comprehensive solutions for issues that affect many women. As conversations about women’s health continue to gain momentum, the FDA’s latest decision may pave the way for further advancements in this important area.
