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U.S. regulators widened the indication of a oral treatment to treat low libido in females to include postmenopausal women up to age 65.

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

Flibanserin was first approved by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

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

Additional women’s health experts expressed support for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be crucial to address postmenopausal women 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 measured in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the enhancement is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was found to be lacking during early studies.

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

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the chance of syncope. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the interactions of mixing the drug with drinking eventually prompted the maker to fund additional studies examining the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“This research 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 reason why the drug was not initially cleared for postmenopausal women.

“There have been side effects like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion 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 drug. 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 prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a different group of women who may benefit.

“I believe it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a wide variety of symptoms that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Androgen therapy is also sometimes prescribed off-label to treat low libido in females, although it is not officially approved for it.

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

“I would have no problem 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 recommendations for increasing libido include:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”