FDA approves first pill to treat low libido in women after menopause

The US Food and Drug Administration (FDA) has approved the medication Addyi (flibanserin) as a “female Viagra” for use to treat low sex drive in women after menopause under the age of 65.

Addyi, a pill to treat low libido in women, will open up new treatment options for older women, but experts caution 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 is increased for people with certain liver problems, people who drink alcohol close to bedtime, and people who take certain antifungals, antivirals, and medicines to treat conditions such as high blood pressure and HIV.

So, it is recommended to avoid taking Addyi within two hours of consuming alcohol to avoid potential interactions and dangerous side effects.

Prior to the announcement this week, the pill, Addyi, was first approved by the FDA in 2015, following a lengthy and contentious review process, to treat hypoactive sexual desire disorder (HSDD) or stress caused by low libido in premenopausal females under the age of 65.

Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, the maker of Addyi, said the approval of the expansion of the drug’s use is a “milestone” in understanding and prioritizing female sexual health.

Addyi, which is sometimes referred to as “female Viagra”, has little in common with the medication from which it draws its nickname. It was originally developed as an antidepressant but was deemed ineffective during early studies.

However, researchers observed improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

Addyi is a nonhormonal pill that acts on brain chemicals that affect mood and appetite. The pill is designed to improve desire by boosting levels of the neurotransmitters dopamine and norepinephrine while decreasing levels of the neurotransmitter serotonin.

These changes happen naturally in response to thoughts of sex in people without low libido. But when people have low libido, thoughts of sex may not result in messages travelling through pathways in the brain that trigger a sexual response.