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The federal agency widened the indication of a oral treatment to address low libido in females to cover postmenopausal women up to the age of sixty-five.

Prior to the announcement, the drug, flibanserin (Addyi), was exclusively cleared to treat 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.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s move to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Additional women’s health experts were supportive for the decision.

“I had few tools for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was originally developed as an antidepressant but was found to be lacking during early studies.

However, researchers noted improvements in measures of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

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

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually led the maker to fund further research examining the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert 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 more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor expressed confusion about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, 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 Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a new population of females who may find help.

“I believe it will benefit this population better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the specialists consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these issues is often a initial approach toward improved intimacy.

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

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also sometimes used without formal approval to treat reduced desire in females, although it is not indicated for it.

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

“I am comfortable recommending 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.

Other recommendations for boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• practicing extended foreplay
• incorporating vibrators or dilators

“It requires an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “This involves knowing 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.”