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U.S. regulators expanded its approval of a daily pill to treat low libido in females to cover postmenopausal women up to age 65.

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

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s move to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Other OB-GYNs voiced approval for the decision.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be crucial 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 news outlets that the approval was “understandable” given the available data.

While in favor, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was first created as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, researchers noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use 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 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 advises allowing a two-hour gap after drinking before taking Addyi to minimize the chance 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 mixing Addyi and alcohol eventually led the pharmaceutical company to fund further research examining the combination. The studies, which were small in scale, showed no additional risk of syncope. But medical professionals had reservations.

“These studies don’t seem very convincing 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 suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“There have been adverse reactions like the fainting spells and lightheadedness 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 age 65.

“It's unclear if that has to do with the intricacies of the drug. 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 simpler guidance 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 new population of women 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 consulted all agreed that the women's sexual desire is influenced by many factors.

So addressing HSDD means engaging with everything from relationship dynamics to hormonal changes.

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, managing these symptoms is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Testosterone is also sometimes used without formal approval to treat reduced desire in females, although it is not officially approved for it.

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

“I would have no problem recommending Addyi 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.

Other suggestions for increasing libido are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “This involves knowing how your body works, your anatomy, 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.”