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U.S. regulators expanded its approval of a daily pill to address low libido in women to now encompass postmenopausal women up to 65 years old.

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

The drug was initially cleared 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 2013. In each instance, the FDA expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile.

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

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional specialists in female health voiced approval for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be significant to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the medication from which it draws its nickname.

This medication was initially researched as an antidepressant but was considered unsuccessful during early studies.

However, researchers observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort.

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

Official guidance advises allowing a two-hour gap after drinking before using the drug to minimize the chance of syncope. If a person has several drinks on a single occasion, the instructions advises skipping the dose entirely.

Claims about the interactions of mixing the drug with drinking eventually led the maker to fund further research examining the interaction. The studies, which were small in scale, showed no increased danger 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 large-scale and certainly aren’t very long,” a health research president stated.

An OB-GYN speculated that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was limited 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 dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire to a new population of females who may find help.

“I believe it will serve 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 all agreed that the female libido is complex and multifaceted.

So addressing HSDD means considering everything from partnership issues to shifts in hormone levels.

Women after menopause experience a broad range of changes that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, treating these issues is often a initial approach toward sexual wellness.

“If somebody came to me 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 systemic hormone therapy as treatments to treat the symptoms of menopause, particularly 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 reduced desire in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing sexual desire include:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating 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 OB-GYN. “This involves understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”