🔗 Share this article

The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to address low libido in women to cover women after menopause up to 65 years old.

Prior to the recent news, the medication, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, 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 injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi applauded the FDA’s decision to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

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

Understanding Addyi, the ‘Female Viagra’?

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

This medication was originally developed as an medication for depression but was found to be lacking during early studies.

Nevertheless, scientists noted improvements in measures of sexual function and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

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 serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before using Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the label recommends not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies investigating the combination. The studies, which were limited in size, demonstrated no additional risk of fainting. But experts had concerns.

“These studies 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 public health expert 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 taking the pill. When you get older, 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.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden 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 specialist.

But it is not a quick fix. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

So treating HSDD means considering everything from relationship dynamics to hormonal changes.

Women after menopause experience a wide variety of symptoms that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, managing these issues is often a first step toward sexual wellness.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Testosterone is also sometimes prescribed off-label to treat low libido in females, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always start with partnership dynamics and closeness.

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

Additional suggestions for boosting libido include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “This involves knowing how your body works, your physiology, 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 sexual pleasure.”