U.S. Food and Drug Administration Grants Approval to Flibanserin, a Libido-Enhancing Treatment for Postmenopausal

U.S. regulators widened the indication of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Prior to the announcement, the medication, Addyi (flibanserin), was only approved to address low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in two thousand fifteen, following a long and debated evaluation period.

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

Today, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional women’s health experts were supportive for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “logical” given the available data.

While in favor, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the benefit is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

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

The drug was initially researched as an antidepressant but was considered unsuccessful during initial trials.

However, researchers observed positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

The label recommends allowing a two-hour gap after drinking before taking Addyi to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies examining the combination. The research, which were limited in size, showed no additional risk of syncope. But medical professionals had concerns.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

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

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at age 65.

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand treatment options 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 health issues,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts interviewed all agreed that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females navigate a broad range of changes that can impact sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“When a patient presents 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 systemic hormone therapy as options to treat the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to address low libido in women, although it is not indicated for it.

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

“I am comfortable recommending flibanserin 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.

Other suggestions for boosting libido are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage in older age,” said an expert. “This involves knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”