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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to address low libido in females to cover postmenopausal women up to 65 years old.

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

The drug was first approved by the FDA in 2015, following a lengthy and contentious evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

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

Other women’s health experts expressed support for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be crucial 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 approval was “logical” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was found to be lacking during initial trials.

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

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

The medication carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label recommends waiting at least two hours after drinking before using the drug to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund further research investigating the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had concerns.

“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 public health expert stated.

An gynecologist suggested that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage 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 broader approval was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a different group of females who may benefit.

“I do think it will benefit this demographic better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the experts interviewed all agreed that the women's sexual desire is complex and multifaceted.

So treating HSDD means considering everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of symptoms that can impact sexual desire. Symptoms of menopause encompass:

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

According to one expert, managing these issues is often a first step toward sexual wellness.

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

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

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a viable choice.

Androgen therapy is also occasionally used without formal approval to address low libido in women, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after having a conversation 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 libido are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• using 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. “This involves understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of orgasm.”