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U.S. regulators broadened the authorized use of a daily pill to address low libido in women to include postmenopausal women up to 65 years old.

Prior to the announcement, the medication, Addyi (flibanserin), was only approved to address low sexual desire in premenopausal females.

The drug was first approved by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

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

Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s move to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional specialists in female health expressed support for the decision.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the existing research.

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is often called “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

This medication was first created as an antidepressant but was considered unsuccessful during initial trials.

However, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant advocacy campaign.

Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before using Addyi to reduce the chance of fainting. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research examining the interaction. The studies, which were small in scale, showed no additional risk of syncope. But medical professionals had reservations.

“These studies don’t seem very convincing to me. They are a beginning, 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 cause why Addyi was not initially cleared for postmenopausal women.

“There have been side effects like the syncopal episodes and dizziness especially in persons who have had an drink 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 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. 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 After Menopause

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

“I do think it will benefit this demographic 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 shifts in hormone levels.

Postmenopausal females navigate a wide variety of changes 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, treating these issues is often a first step toward sexual wellness.

“If somebody came to me with libido issues, 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 treatments to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope 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 consider it as a viable choice.

Androgen therapy is also occasionally used without formal approval to treat low libido in women, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about sexual desire almost always start with relationships and intimacy.

“I would have no problem recommending 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 suggestions for increasing sexual desire include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an expert. “That means understanding 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.”