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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 the age of sixty-five.

Prior to this week's decision, the drug, Addyi (flibanserin), was solely authorized to treat low sexual desire in premenopausal females.

This medication was originally authorized by the FDA in 2015, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of flibanserin commended the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs expressed support for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “understandable” given the clinical evidence.

While in favor, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

What is Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

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

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major advocacy campaign.

The medication carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

“This research aren't 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 gynecologist speculated 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 syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still broaden treatment options for HSDD to a new population of females who may find help.

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

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

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

Women after menopause experience a broad range of changes that can impact sexual desire. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, managing these issues is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She expressed hope 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 view it as a viable choice.

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

But besides medication, experts say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“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 recommendations for increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexuality and menopause 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 aroused, and ultimately to have a peak of sexual pleasure.”