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The federal agency widened the indication of a oral treatment to treat low libido in females to include postmenopausal women up to 65 years old.

Before this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was originally authorized by the FDA in 2015, following a long and debated 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, effectiveness, and an concerning balance of risks and benefits.

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

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

Additional OB-GYNs voiced approval for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be very important to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “logical” given the available data.

While in favor, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the improvement is not dramatic. Does it justify taking a drug daily and not getting bang for your buck?”

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

Flibanserin, which is often called “female Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was initially researched as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, researchers observed improvements in aspects of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

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

Claims about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, showed no increased danger of syncope. But medical professionals had reservations.

“These studies aren't 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 gynecologist suggested that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. If you take 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

Despite these risks, Addyi could still expand treatment options for HSDD to a different group of women who may find help.

“I believe it will serve this population 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 universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a broad range of symptoms that can affect sexual desire. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these symptoms is often a initial approach toward improved intimacy.

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a viable choice.

Testosterone is also occasionally used without formal approval to treat low libido in females, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem recommending 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 increasing libido are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexuality and menopause in later life,” said an expert. “This involves understanding how your body works, your anatomy, 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.”