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The Food and Drug Administration (FDA) widened the indication of a oral treatment to address low libido in women to include postmenopausal women up to 65 years old.

Prior to this week's decision, the medication, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

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

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of flibanserin applauded the FDA’s action to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional specialists in female health were supportive for the decision.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance 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 issues with 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: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Women's Desire Pill’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

However, researchers noted improvements in aspects of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises allowing a two-hour gap after drinking before taking the drug to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of syncope. But experts had reservations.

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

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

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. Reviewing 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 clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a new population of women who may find help.

“I believe it will serve this population better as long as they have no other medical problems,” said an OB-GYN.

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

So addressing low desire means considering everything from partnership issues to hormonal changes.

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

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Testosterone is also occasionally prescribed off-label to treat low libido in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem prescribing flibanserin 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.

Other recommendations for increasing sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an entire whole body approach to sexual health and menopause in older age,” said an expert. “That means 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 peak of sexual pleasure.”