The U.S. Food and Drug Administration (FDA) approved the drug Addyi (flibanserin) as “female Viagra” to treat low sexual desire in postmenopausal women under 65 years of age.
Addyi, a pill to treat low libido in women, will open up new treatment options for older women, but experts warn that treating low libido requires a “whole-body approach.”
In a late-stage clinical trial that randomly assigned 949 postmenopausal women with low libido to take Addyi or a placebo for 24 weeks, participants taking the drug reported significant increases in sexual desire and the number of satisfying sexual encounters they had.
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Addyi poses a risk of dangerously low blood pressure and fainting. The risk increases in people with certain liver problems, people who drink alcohol close to bedtime, and people taking certain antifungals, antivirals, and medications to treat conditions such as high blood pressure and HIV.
Therefore, it is recommended to avoid taking Addyi within two hours of consuming alcohol to avoid possible interactions and dangerous side effects.
Prior to this week’s announcement, the Addyi pill was first approved by the FDA in 2015, after a long and contentious review process, to treat hypoactive sexual desire disorder (HSDD), or stress caused by low libido, in premenopausal women under age 65.
Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, maker of Addyi, said the approval of the expanded use of the drug is a “milestone” in understanding and prioritizing female sexual health.
Addyi, sometimes referred to as “female Viagra,” has little in common with the drug from which it takes its nickname. It was originally developed as an antidepressant, but was considered ineffective during early studies.
However, researchers noted improvements in measures of sexual function and focused their attention on the drug’s potential as a treatment for low libido.
Addyi is a non-hormonal pill that targets brain chemicals that affect mood and appetite. The pill is designed to improve desire by increasing levels of the neurotransmitters dopamine and norepinephrine while decreasing levels of the neurotransmitter serotonin.
These changes occur naturally in response to sexual thoughts in people without low libido. But when people have a low libido, sexual thoughts may not lead to messages traveling through pathways in the brain that trigger a sexual response.