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U.S. regulators expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to age 65.

Prior to this week's decision, the drug, flibanserin (Addyi), was only approved to address low sexual desire in women of reproductive age.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s move to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Other specialists in female health expressed support for the decision.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “quite reasonable” given the available data.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the benefit is not dramatic. Is it worthwhile taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has few similarities with the drug from which it draws its nickname.

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

Nevertheless, scientists noted positive changes in aspects of libido and arousal and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

The medication carries a boxed (“black box”) warning for serious side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label advises waiting at least two hours after drinking before using the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the maker to fund additional studies examining the combination. The studies, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had reservations.

“These studies don’t seem very convincing to me. They are a beginning, 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 reason 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 taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited 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, it’s really wide-ranging. 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 in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for HSDD to a new population of women who may find help.

“I do think it will serve this population better as long as they have no other health issues,” 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 HSDD means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a wide variety of changes that can impact libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly dryness.

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

Testosterone is also sometimes prescribed off-label to treat low libido 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 libido almost always begin by focusing on relationships and intimacy.

“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.

Other suggestions for increasing libido are:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”