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U.S. regulators widened the indication of a daily pill to treat low libido in women to now encompass postmenopausal women up to age 65.

Prior to this week's decision, the medication, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in women of reproductive age.

This medication was first approved by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of flibanserin praised 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 were supportive for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “logical” given the available data.

While in favor, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists observed improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

The medication carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

The label advises allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the effects of combining the drug with drinking eventually prompted the maker to fund further research examining the combination. The research, which were small in scale, demonstrated no additional risk of syncope. But experts had concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

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

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

Another doctor expressed confusion about why the broader approval was limited at age 65.

“I don’t know if that has to do with the complexity of the medication. 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 simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population of females who may find help.

“I do think it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a magic bullet. In fact, the specialists 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 hormonal changes.

Postmenopausal females navigate a wide variety of symptoms that can impact libido. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward improved intimacy.

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

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to address 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 sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing flibanserin 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 recommendations for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• using sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” 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 climax of orgasm.”