U.S. Food and Drug Administration Approves Flibanserin, a Libido-Enhancing Treatment for Females Beyond Menopause

The Food and Drug Administration (FDA) widened the indication of a daily pill to address low libido in women to include women after menopause up to the age of sixty-five.

Prior to the recent news, the pill, Addyi (flibanserin), was solely authorized to address low sexual desire in women of reproductive age.

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

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

Today, 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 chief executive of the pharmaceutical company of Addyi applauded the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs expressed support for the decision.

“Previously, options were limited 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 patient population could be crucial to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “quite reasonable” given the existing research.

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

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

The drug was originally developed as an medication for depression 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 therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

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

The label advises waiting at least two hours after drinking before using Addyi to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were small in scale, showed no increased danger of syncope. But experts had concerns.

“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 suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“Patients have experienced adverse reactions like the fainting spells 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 effects like that,” she said.

Another doctor expressed confusion 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 drug. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a new population of females who may find help.

“I do think it will benefit this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a simple solution. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

So addressing HSDD means considering everything from partnership issues to hormonal changes.

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

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these symptoms is often a first step 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 alleviate the effects of menopause, particularly vaginal dryness.

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

Testosterone is also occasionally used without formal approval to address low libido in females, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending flibanserin 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 suggestions for increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “That means understanding 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.”