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The federal agency expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

Prior to this week's decision, the drug, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

The drug was first approved by the FDA in 2015, following a long and debated review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of flibanserin applauded the FDA’s action to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Other specialists in female health expressed support for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the available data.

While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences 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.

Nevertheless, researchers observed positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following further studies and a significant lobbying effort.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

The label advises allowing a two-hour gap after drinking before taking Addyi to minimize 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 interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were limited in size, showed no increased danger of syncope. 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 aren’t very long,” a public health expert stated.

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

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

Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, 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 prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for HSDD 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 OB-GYN.

But it is not a magic bullet. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

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

Women after menopause navigate a broad range of symptoms that can affect libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, managing these symptoms is often a first step toward improved intimacy.

“If somebody came to me 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 alleviate the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also occasionally prescribed off-label to address reduced desire in females, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem recommending 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.

Other suggestions for boosting sexual desire include:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” 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 excited, and ultimately to have a peak of orgasm.”