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The Food and Drug Administration (FDA) widened the indication of a daily pill to manage low libido in women to cover women after menopause up to age 65.

Prior to the announcement, the medication, Addyi (flibanserin), was only approved to address low sexual desire in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s action to broaden the drug’s indication, 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 recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be crucial to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the existing research.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the enhancement is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it gets its informal name.

This medication was originally developed as an antidepressant but was found to be lacking during initial trials.

Nevertheless, scientists noted improvements in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

Official guidance recommends allowing a two-hour gap after drinking before using Addyi to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Claims about the interactions of combining the drug with drinking eventually led the maker to fund additional studies examining the interaction. The studies, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had concerns.

“These studies don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An gynecologist suggested that this may have been part of the cause why the drug was not originally approved for older females.

“There have been side effects like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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 population 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 influenced by many factors.

So treating low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a broad range of symptoms that can impact libido. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, managing these issues is often a first step toward improved intimacy.

“When a patient presents with concerns about desire, 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 symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a viable choice.

Androgen therapy is also occasionally used without formal approval to address reduced desire in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always start with 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 emotional and relational factors going on,” she said.

Additional suggestions for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take 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 sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of orgasm.”