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The federal agency broadened the authorized use of a oral treatment to treat low libido in women to include postmenopausal women up to 65 years old.

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

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

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, 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 “significant step” in understanding and prioritizing female sexual health.

Additional specialists in female health expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the clinical evidence.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

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

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

However, scientists observed 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, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

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

Official guidance advises waiting at least two hours after drinking before using Addyi to minimize the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the maker to fund further research investigating the interaction. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had concerns.

“These studies 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 gynecologist suggested that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

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

Another doctor expressed uncertainty about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. 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 clearer instructions because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for low desire to a different group of women who may find help.

“I do think it will serve 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 universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing HSDD means engaging with everything from partnership issues 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
• bladder leakage

According to one expert, treating these issues is often a first step toward sexual wellness.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to address reduced desire in females, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Discussions about libido almost always start with partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “That means knowing how your body works, your anatomy, 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 orgasm.”