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The federal agency expanded its approval of a oral treatment to address low libido in women to now encompass women after menopause up to age 65.

Before the recent news, the drug, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in women of reproductive age.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the maker of flibanserin praised the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Other women’s health experts voiced approval for the decision.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be significant to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “understandable” given the existing research.

Although supportive, the expert was guarded in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the magnitude of the improvement is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

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

The drug was first created as an antidepressant but was found to be lacking during initial trials.

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

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

Addyi carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

The label advises allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the maker to fund further research examining the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had concerns.

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

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

“There have been adverse reactions like the fainting spells and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. If you take 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.

Addressing Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a new population of women who may benefit.

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

But it is not a simple solution. In fact, the experts interviewed 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 navigate a broad range of changes that can impact sexual desire. Symptoms of menopause include:

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

According to 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 hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly dryness.

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

Androgen therapy is also sometimes prescribed off-label to address reduced desire in females, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem prescribing Addyi 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 boosting libido are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended foreplay
• using 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 knowing 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 peak of orgasm.”