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

Before the recent news, the pill, flibanserin (Addyi), was solely authorized to address low sexual desire in women of reproductive age.

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

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s action to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional specialists in female health were supportive 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 OB-GYN. “Getting the FDA approval for this patient population could be significant to help postmenopausal women 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 “understandable” given the available data.

While in favor, the expert was measured in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

What is Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is often called “female Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

Nevertheless, researchers noted positive changes in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The studies, which were limited in size, showed no increased danger of syncope. But experts had concerns.

“This research don’t seem very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause why the drug was not originally approved for older females.

“There have been adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. 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 simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a new population of females who may benefit.

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

But it is not a quick fix. In fact, the experts interviewed all agreed that the female libido is complex and multifaceted.

So treating HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward improved intimacy.

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

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

But in addition to drugs, experts say that lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing sexual desire are:

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

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “This involves knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”