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The federal agency widened the indication of a oral treatment to manage low libido in women to cover postmenopausal women up to age 65.

Before the announcement, the drug, Addyi (flibanserin), was only approved to address low sexual desire in premenopausal females.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Today, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s decision to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs expressed support for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval was “logical” given the clinical evidence.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree 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’?

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

The drug was first created as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, scientists observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of syncope. If a person has three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the maker to fund further research examining the interaction. The research, which were limited in size, showed no increased danger of syncope. But experts had reservations.

“These studies don’t seem very convincing 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 older females.

“There have been side effects like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a different group of women who may benefit.

“I believe it will benefit this demographic 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 interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a broad range of symptoms that can impact sexual desire. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as options to treat the symptoms of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a viable choice.

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

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

“I am comfortable prescribing flibanserin after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” 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 climax of orgasm.”