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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to 65 years old.

Before this week's decision, the drug, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.

Flibanserin was first approved by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s move to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other women’s health experts expressed support for the decision.

“There was nothing for me to recommend because everything 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 problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “understandable” given the existing research.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

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

The drug was initially researched as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, researchers noted positive changes in aspects of libido and arousal 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 further studies and a considerable lobbying effort.

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

Official guidance recommends waiting at least two hours after consuming alcohol before using the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the combination. The studies, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

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

“There have been side effects like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

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

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, 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 treatment options for low desire to a new population of females who may find help.

“I believe it will benefit this demographic 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 women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can impact sexual desire. Menopausal symptoms encompass:

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

As noted by one expert, managing these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat reduced desire in women, although it is not indicated for it.

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

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

Other suggestions for boosting sexual desire include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

“It requires an entire whole body approach to sexual health and this life stage in later life,” said an expert. “That means understanding 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 orgasm.”