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The Food and Drug Administration (FDA) widened the indication of a oral treatment to treat low libido in females to include postmenopausal women up to the age of sixty-five.

Before this week's decision, the drug, Addyi (flibanserin), was solely authorized to treat low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

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

Currently, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of flibanserin praised the FDA’s action to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Other women’s health experts voiced approval for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be crucial to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not overwhelming. Does it justify taking a drug daily and not seeing a major effect?”

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

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

This medication was first created as an antidepressant but was deemed ineffective during early studies.

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

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

The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before using the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Claims about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had reservations.

“These studies don’t seem very persuasive 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 Addyi was not originally approved for older females.

“There have been side effects like the syncopal episodes and lightheadedness especially in individuals who have had an drink 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 uncertainty about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the complexity of the drug. 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 clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a new population of females who may benefit.

“I believe it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

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 considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a broad range of changes that can affect sexual desire. Symptoms of menopause include:

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

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the effects 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 concerned about it and to consider it as a treatment option.

Testosterone is also occasionally prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing flibanserin 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 recommendations for boosting libido include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “That means understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”