🔗 Share this article

U.S. regulators broadened the authorized use of a once-a-day medication to treat low libido in females to include women after menopause up to 65 years old.

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

The drug was initially cleared by the FDA in two thousand fifteen, following a long and debated review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA cited issues about safety, effectiveness, and an concerning balance of risks and benefits.

Now, 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 2019.

The founder and CEO of the maker of Addyi praised the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Other women’s health experts expressed support for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be significant to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the available data.

Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was first created as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, scientists observed positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious side effects, 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 chance of syncope. If a person has several drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The studies, which were limited in size, showed no increased danger of fainting. But experts had concerns.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a public health expert stated.

An gynecologist suggested that this may have been part of the reason why the drug was not initially cleared for older females.

“Patients have experienced side effects like the syncopal episodes and lightheadedness 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 echoed confusion about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, 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.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a different group of women who may benefit.

“I believe it will serve this population 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 consulted universally acknowledged that the female libido is complex and multifaceted.

So treating low desire means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a broad range of changes that can impact sexual desire. Symptoms of menopause encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

According to one expert, managing these symptoms is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a viable choice.

Androgen therapy is also occasionally used without formal approval to treat low libido in women, although it is not officially approved for it.

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for boosting sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “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 excited, and ultimately to have a climax of orgasm.”