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The federal agency expanded its approval of a oral treatment to manage low libido in females to cover women after menopause up to the age of sixty-five.

Before this week's decision, the pill, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in premenopausal females.

This medication was first approved by the FDA in 2015, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s action to expand 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 decision.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be crucial to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “logical” given the available data.

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is often called “female Viagra,” has little in common with the drug from which it gets its informal name.

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

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

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

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

Official guidance advises allowing a two-hour gap after drinking before using the drug to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were small in scale, showed 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 aren’t very long,” a health research president stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.

“Patients have experienced 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 older, you become more susceptible to effects like that,” she said.

Another doctor expressed uncertainty about why the broader approval was capped at age 65.

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a different group of women who may find help.

“I do think it will serve 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 specialists consulted all agreed that the female libido is complex and multifaceted.

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a broad range of changes that can affect libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

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

“If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Androgen therapy is also sometimes used without formal approval to treat reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for increasing sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “This involves knowing 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 sexual pleasure.”