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The Food and Drug Administration (FDA) widened the indication of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to age 65.

Before the recent news, the drug, Addyi (flibanserin), was solely authorized to treat low sexual desire in women of reproductive age.

The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of Addyi applauded the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional women’s health experts voiced approval for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to address postmenopausal women who want to have 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 available data.

While in favor, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?”

Understanding Flibanserin, the ‘Women's Desire Pill’?

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it gets its informal name.

This medication was first created as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, scientists observed improvements in measures of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the maker to fund further research examining the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had reservations.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

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

“Patients have experienced side effects like the fainting spells 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 echoed 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 medication. Reviewing a list of the dos and don’ts, it’s really wide-ranging. 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.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a new population of women who may benefit.

“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 simple solution. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females experience a wide variety of changes that can impact libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

According to one expert, treating these issues 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? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to address low libido in females, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Conversations about sexual desire almost always start with 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 emotional and relational factors going on,” she said.

Other suggestions for boosting libido include:

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

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “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 excited, and ultimately to have a peak of orgasm.”