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The federal agency expanded its approval of a once-a-day medication to treat low libido in women to include postmenopausal women up to 65 years old.

Before the recent news, the pill, Addyi (flibanserin), was only approved to treat low sexual desire in premenopausal females.

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

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

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

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional women’s health experts voiced approval for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “logical” given the clinical evidence.

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

Understanding Addyi, the ‘Female Viagra’?

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

The drug was originally developed as an antidepressant but was found to be lacking during early studies.

Nevertheless, researchers noted positive changes in aspects of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to reduce the chance of fainting. If a person has three or more alcoholic drinks on a given day, the label advises skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had reservations.

“This research don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert stated.

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

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a new population of women who may benefit.

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

But it is not a magic bullet. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females experience a wide variety of symptoms that can impact libido. Menopausal symptoms include:

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

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

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen 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 “serious” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a viable choice.

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

But besides medication, experts say that personal habits should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending 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.

Other recommendations for boosting sexual desire are:

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

“It requires an comprehensive, holistic strategy to sexual health and this life stage 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 aroused, and ultimately to have a peak of sexual pleasure.”