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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to treat low libido in females to cover women after menopause up to 65 years old.

Prior to this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was originally authorized by the FDA in two thousand fifteen, following a long and debated review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs voiced approval for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the existing research.

Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was first created as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, researchers observed improvements in measures of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a major lobbying effort.

The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label advises waiting at least two hours after drinking before taking Addyi to reduce the risk of fainting. If a person consumes several drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the combination. The research, which were small in scale, showed no increased danger of fainting. But medical professionals had reservations.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why the drug was not originally approved for older females.

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options for low desire to a different group of females who may find help.

“I do think it will serve this population better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted.

So addressing HSDD means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a wide variety of changes that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, managing these issues is often a initial approach toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also sometimes prescribed off-label to treat low libido in women, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for increasing libido are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an expert. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”