FDA Expands Approval for Addyi, Empowering Women Over 65 to Regain Libido

U.S. health officials have expanded approval of Addyi, a once-a-day pill aimed at boosting female libido, to include postmenopausal women up to 65 years old. This decision, announced by the Food and Drug Administration on Monday, broadens the drug's use to older women who have gone through menopause. According to the FDA's announcement, Addyi, marketed by Sprout Pharmaceuticals, was initially approved 10 years ago for premenopausal women who report emotional stress due to low sex drive. However, sales of the drug fell short of Wall Street's initial expectations, with the company facing challenges in promoting the product due to its unpleasant side effects, including dizziness and nausea. The expanded approval comes as the FDA approved a second drug for low female libido, an on-demand treatment, in 2019. Despite this, Addyi's sales have continued to struggle, with the company's revenue from the drug declining in recent years. In 2020, Sprout Pharmaceuticals reported revenue of $4.8 million from Addyi sales, down from $6.3 million in 2019. The market for female libido treatments is relatively small, with estimates suggesting that only a small percentage of women experience low libido. However, the expanded approval of Addyi could provide a boost to the company's sales, particularly among older women who may be experiencing menopause-related symptoms. Sprout Pharmaceuticals has faced criticism for its marketing efforts, with some accusing the company of downplaying the drug's side effects. The company has also faced challenges in competing with other treatments for low libido, including hormone replacement therapy and counseling. The FDA's decision to expand approval of Addyi is seen as a positive step for women's health, providing them with more options for treating low libido. However, the company will need to address the challenges it has faced in promoting the product and competing with other treatments. In the future, Sprout Pharmaceuticals may focus on expanding its marketing efforts to reach a wider audience, including older women who may be experiencing menopause-related symptoms. The company may also explore new partnerships or collaborations to help promote the product and increase sales. Overall, the expanded approval of Addyi is a significant development for women's health, providing them with more options for treating low libido. However, the company will need to address the challenges it has faced in promoting the product and competing with other treatments to achieve long-term success.