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The federal agency widened the indication of a oral treatment to address low libido in women to cover postmenopausal women up to the age of sixty-five.

Before the announcement, the drug, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

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

Now, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s action to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health voiced approval for the decision.

“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 clearance for this group of women could be significant to address postmenopausal women 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 approval was “logical” given the available data.

While in favor, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the enhancement is not overwhelming. Does it justify taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, 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.

This medication was initially researched as an medication for depression but was considered unsuccessful during initial trials.

However, scientists noted positive changes in aspects of sexual function and shifted focus to the drug’s potential as a treatment 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.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

Official guidance recommends waiting at least two hours after drinking before taking the drug to reduce the risk of fainting. If a person has three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the interaction. The studies, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had reservations.

“These studies 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 OB-GYN suggested that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects 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 drug. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population 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 specialists interviewed universally acknowledged that the female libido is complex and multifaceted.

So addressing low desire means engaging with everything from partnership issues to shifts in hormone levels.

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

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

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

“If somebody came to me 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 hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also occasionally used without formal approval 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 prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing sexual desire include:

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

“You have to take an entire whole body approach to sexual health 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 aroused, and ultimately to have a climax of sexual pleasure.”