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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

Prior to this week's decision, the pill, flibanserin (Addyi), was solely authorized to address low sexual desire in women of reproductive age.

This medication was originally authorized by the FDA in 2015, following a long and debated review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

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

Additional women’s health experts voiced approval for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the available data.

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not substantial. Does it justify taking a drug every single day and not experiencing a dramatic change?”

What is Flibanserin, the ‘Women's Desire Pill’?

Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was initially researched as an antidepressant but was considered unsuccessful during early studies.

However, scientists noted positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund further research examining the combination. The studies, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An OB-GYN speculated that this may have been part of the cause why the drug was not originally approved for older females.

“Patients have experienced 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 echoed uncertainty about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a new population of females who may benefit.

“I believe it will benefit 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 interviewed all agreed that the women's sexual desire is influenced by many factors.

So treating HSDD means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a wide variety of changes that can impact libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these issues is often a first step toward improved intimacy.

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a viable choice.

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

But besides medication, doctors say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”