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The federal agency widened the indication of a daily pill to address low libido in females to now encompass women after menopause up to the age of sixty-five.

Prior to the announcement, the medication, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in two thousand fifteen, following a long and debated review process.

The FDA previously rejected 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.

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s move to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional OB-GYNs voiced approval for the decision.

“Previously, options were limited for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “quite reasonable” given the available data.

Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the placebo, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “female 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.

However, scientists noted positive changes in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a major advocacy campaign.

Addyi carries a serious safety warning for severe side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label recommends waiting at least two hours after drinking before taking Addyi to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had reservations.

“These studies aren't very convincing 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 reason why Addyi was not originally approved for older females.

“There have been adverse reactions like the fainting spells and lightheadedness 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 uncertainty about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population of females who may benefit.

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

But it is not a simple solution. In fact, the specialists consulted all agreed that the female libido is complex and multifaceted.

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

Women after menopause experience a wide variety of symptoms that can impact libido. Menopausal symptoms include:

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

According to one expert, treating these symptoms 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? Is intercourse painful?” she said.

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

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also sometimes 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 considered. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing libido include:

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

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an expert. “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 aroused, and ultimately to have a peak of orgasm.”