FDA Approves Flibanserin, a Desire-Boosting Drug for Postmenopausal

U.S. regulators broadened the authorized use of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to age 65.

Before the recent news, the medication, flibanserin (Addyi), was only approved to address low sexual desire in women of reproductive age.

This medication was initially cleared by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the maker of Addyi praised the FDA’s action to expand the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs 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 clearance for this group of women could be significant to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “logical” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has little in common with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was found to be lacking during early studies.

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

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label advises allowing a two-hour gap after drinking before using Addyi to minimize the risk of syncope. If a person consumes several drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“This research don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president 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 more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was capped at age 65.

“It's unclear 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 clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a different group of women who may find help.

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

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors.

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

Postmenopausal females navigate a broad range of changes that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, treating these issues is often a first step toward improved intimacy.

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

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

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

Testosterone is also occasionally used without formal approval to address reduced desire in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “That means understanding 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.”