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The federal agency widened the indication of a once-a-day medication to manage low libido in women to cover women after menopause up to 65 years old.

Prior to the announcement, the pill, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in women of reproductive age.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the only FDA-approved oral medication 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 expand the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Additional OB-GYNs were supportive 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. “Securing the FDA approval for this group of women could be crucial to help women after menopause 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 approval was “understandable” given the available data.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was deemed ineffective during initial trials.

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

After two rejections, flibanserin was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of fainting. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, which were limited in size, demonstrated no increased danger of syncope. But experts had concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

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

Another doctor expressed uncertainty about why the broader approval was limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, 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.

Treating Diminished Sexual Desire 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 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 interviewed universally acknowledged that the female libido is complex and multifaceted.

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

Postmenopausal females experience a wide variety of changes that can impact sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

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

“When a patient presents with concerns about desire, 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 effects of menopause, particularly vaginal dryness.

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

Androgen therapy is also sometimes used without formal approval to address low libido in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Discussions about libido almost always start with partnership dynamics and closeness.

“I would have no problem recommending flibanserin 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.

Additional recommendations for increasing libido include:

• getting more sleep
• exercising
• staying active
• using over-the-counter lubricants
• practicing extended foreplay
• using sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “That means 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 peak of sexual pleasure.”