WASHINGTON — US health officials expanded approval much discussed drug aimed at increasing female libidostating that the once-daily pill can now be taken by women over 65 years of age.
On Monday, the Food and Drug Administration announced it would expand the use of the drug to older women who have gone through menopause. Tablet, Addiewas first approved 10 years ago for premenopausal women who report emotional distress due to low sex drive.
Addyi, for sale Octopus PharmaceuticalsIt was initially expected to become a blockbuster drug, filling an important niche in women's health. But the drug had unpleasant side effects, including dizziness and nausea, and came with a warning about the dangers of combining it with alcohol. The boxed warning, the FDA's most serious warning, warns that drinking alcohol while taking the pill may cause dangerously low blood pressure and fainting.
Sales of Addyi, which targets brain chemicals that affect mood and appetite, have been limited. In 2019, the FDA approved a second drug for low female libido, an on-demand injection that targets a different set of neurological chemicals.
Sprout CEO Cindy Eckert said in a statement that the approval “reflects a decade of persistent work with the FDA to fundamentally change the way women's sexual health is understood and prioritized.” The Raleigh, North Carolina-based company announced the FDA update in a press release Monday.
A condition of alarmingly low sexual appetite called hypoactive sexual desire disorder has been recognized since the 1990s and is believed to affect a significant proportion of American women, according to surveys. Following the runaway success of Viagra for men in the 1990s, drug makers began pouring money into research and potential treatments for sexual dysfunction in women.
But diagnosing the condition is difficult because of the many factors that can affect libido, especially after menopause when a drop in hormone levels causes a range of biological changes and medical symptoms. Before prescribing medications, doctors must rule out a number of other problems, including relationship problems, illness, depression and other mental disorders.
The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.
The FDA twice rejected Addyi before its approval in 2015, citing the drug's moderate effectiveness and troubling side effects. The approval came after a lobbying campaign led by the company and its Even the Score supporters, which framed the lack of options for women's libido as a women's rights issue.
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