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U.S. regulators expanded its approval of a once-a-day medication to treat low libido in females to now encompass women after menopause up to 65 years old.

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

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

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the maker of Addyi praised the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional OB-GYNs were supportive for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the improvement is not dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was initially researched as an antidepressant but was found to be lacking during early studies.

However, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

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

Addyi carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually led the maker to fund further research investigating the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“This research 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 gynecologist speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

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

Another doctor expressed confusion 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, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a different group of females who may find help.

“I do think it will benefit this population better as long as they have no other medical problems,” said an specialist.

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a wide variety 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 first step toward improved intimacy.

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments 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 view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to treat low libido 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 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 boosting libido are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in older age,” said an expert. “This involves knowing how your body works, your physiology, 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.”