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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to manage low libido in women to cover women after menopause up to age 65.

Prior to the recent news, the drug, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

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

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s action to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

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

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be very important to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “understandable” given the available data.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

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

This medication was first created as an medication for depression but was considered unsuccessful during early studies.

However, scientists observed improvements in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

The medication carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label recommends waiting at least two hours after drinking before using the drug to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the instructions recommends skipping the dose entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the combination. The research, which were limited in size, demonstrated no additional risk of fainting. But experts had reservations.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An gynecologist suggested that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“Patients have experienced side effects like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, 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.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still broaden treatment options for HSDD to a new population of women who may find help.

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

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

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

Women after menopause navigate a broad range of symptoms that can impact sexual desire. Symptoms of menopause encompass:

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

According to one expert, treating these issues is often a first step toward sexual wellness.

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

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

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

Androgen therapy is also sometimes used without formal approval to treat reduced desire in females, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy.

“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 psychosocial issues going on,” she said.

Additional suggestions for increasing sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an expert. “This involves 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 climax of sexual pleasure.”