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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to manage low libido in females to cover postmenopausal women up to age 65.

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

This medication was initially cleared by the FDA in 2015, following a protracted and controversial review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency expressed reservations about safety, 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 injectable used when desired, in 2019.

The founder and CEO of the maker of flibanserin applauded the FDA’s decision to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

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

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was initially researched as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, scientists observed improvements in measures of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

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

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

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

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research investigating the interaction. The research, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns.

“These studies aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

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

“Patients have experienced side effects 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 susceptible to things like that,” she said.

Another doctor expressed 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, 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 prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options for HSDD 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 medical problems,” said an OB-GYN.

But it is not a quick fix. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

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

Women after menopause experience a wide variety of changes that can impact sexual desire. Symptoms of menopause include:

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

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

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less concerned 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. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing 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.

Other suggestions for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”