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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to manage low libido in females to include postmenopausal women up to 65 years old.

Prior to the announcement, the pill, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s decision to expand the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Other women’s health experts voiced approval for the decision.

“There was nothing for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be very important to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the placebo, but the degree of the enhancement is not dramatic. Does it justify taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it draws its nickname.

This medication was originally developed as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, scientists noted positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before using Addyi to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the combination. The research, which were small in scale, showed no additional risk of syncope. But medical professionals had concerns.

“This research aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An gynecologist speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“Patients have experienced side effects like the fainting spells and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

“I believe it will serve this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the female libido is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

Women after menopause navigate a broad range of changes that can impact libido. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, managing these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to address reduced desire in women, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”