FDA OKs libido-boosting pill for women who have gone through menopause

FDA Expands Approval of Female Libido Drug to Postmenopausal Women

U.S. health officials have broadened the approval for a controversial female libido drug, allowing its use in women over 65 who have gone through menopause. The Food and Drug Administration’s announcement on Monday extends access to Addyi, a medication first approved a decade ago for premenopausal women experiencing emotional distress due to low sexual desire.

Addyi, marketed by Sprout Pharmaceuticals, works by targeting brain chemicals that influence mood and appetite. The once-daily pill was initially projected to become a groundbreaking treatment in women’s health when it received its first approval in 2015, but its adoption has been limited due to concerning side effects and strict usage guidelines.

The medication carries a serious boxed warning – the FDA’s most severe caution – alerting users that combining the drug with alcohol can cause dangerous drops in blood pressure and fainting. Additional side effects include dizziness and nausea, which have dampened enthusiasm for what was once expected to be a blockbuster drug.

Sprout Pharmaceuticals CEO Cindy Eckert celebrated the expanded approval in a statement released Monday from the company’s Raleigh, North Carolina headquarters, saying it “reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.”

The condition Addyi treats, hypoactive sexual desire disorder, has been recognized in medical literature since the 1990s. According to various surveys, it affects a significant portion of American women. Interest in developing treatments surged following the remarkable commercial success of Viagra for men in the late 1990s, prompting pharmaceutical companies to invest heavily in research targeting female sexual dysfunction.

However, diagnosing the condition remains complex, especially in postmenopausal women, as numerous factors can influence libido. The natural hormonal changes that occur during menopause trigger various biological shifts and medical symptoms that can affect sexual desire. Medical guidelines require physicians to rule out relationship problems, medical conditions, depression, and other mental health disorders before prescribing medication like Addyi.

The condition itself remains somewhat controversial in medical circles. Some psychologists contend that low sexual desire should not be classified as a medical problem requiring pharmaceutical intervention, reflecting ongoing debates about the medicalization of normal human variation in sexual interest.

Addyi’s path to FDA approval was not straightforward. The agency rejected the drug twice before its 2015 approval, citing modest effectiveness and concerning side effects. The eventual approval followed an intensive lobbying campaign by Sprout Pharmaceuticals and its supporters through a coalition called Even the Score, which framed the lack of treatment options for female sexual desire as a women’s rights issue.

In 2019, the FDA approved a second medication for low female libido – an on-demand injection that works through different neurological pathways than Addyi. This alternative offers a different approach to treatment, potentially addressing some patients’ needs more effectively.

The expanded approval for postmenopausal women represents a significant market opportunity for Sprout Pharmaceuticals, as it opens access to the medication for millions of additional potential patients. However, the same safety concerns and effectiveness questions that limited the drug’s adoption among younger women will likely persist in this expanded population.

As with its original approval, healthcare providers will need to carefully weigh the potential benefits against the known risks when considering Addyi as a treatment option for their older patients experiencing distress from low sexual desire.