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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to age 65.

Prior to this week's decision, the drug, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

The drug was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of flibanserin praised the FDA’s move to expand the drug’s approval, calling it a “milestone” in advancing and focusing on female sexual health.

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

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “logical” given the existing research.

While in favor, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, scientists observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a major lobbying effort.

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

The label advises waiting at least two hours after drinking before using the drug to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research examining the combination. The research, which were small in scale, showed no increased danger of fainting. But experts had reservations.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale 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 postmenopausal women.

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

Another doctor echoed uncertainty about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a different group of women who may find help.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a simple solution. In fact, the specialists interviewed universally acknowledged that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a broad range of changes that can affect libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, treating these symptoms is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

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

Additional recommendations for boosting sexual desire are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “That means understanding 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 climax of orgasm.”