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The federal agency expanded its approval of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to age 65.

Before this week's decision, the pill, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

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

Today, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s decision to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional OB-GYNs expressed support for the regulatory move.

“I had few tools for me to recommend 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 wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “understandable” given the available data.

While in favor, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

However, scientists observed positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking the drug to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund further research examining the combination. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had reservations.

“These studies aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An gynecologist suggested that this may have been part of the cause why Addyi was not originally approved for older females.

“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 sensitive to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the complexity 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 simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire to a different group of females who may benefit.

“I do think it will serve this demographic 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 universally acknowledged that the female libido is influenced by many factors.

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

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward improved intimacy.

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

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly vaginal dryness.

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

Testosterone 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, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem prescribing Addyi 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 libido include:

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

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “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 aroused, and ultimately to have a climax of sexual pleasure.”