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

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

This medication was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

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

Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of Addyi commended the FDA’s decision to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other specialists in female health expressed support for the regulatory move.

“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 patient population could be crucial to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the available data.

While in favor, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, 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 antidepressant but was found to be lacking during initial trials.

Nevertheless, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

The label advises waiting at least two hours after drinking before taking Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of mixing the drug with drinking eventually led the maker to fund further research investigating the combination. The studies, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had concerns.

“These studies don’t seem 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 OB-GYN suggested that this may have been part of the cause why the drug 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 taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi 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 medical problems,” said an specialist.

But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating HSDD means considering everything from relationship dynamics to shifts in hormone levels.

Women after menopause navigate a wide variety of changes that can affect libido. Symptoms of menopause encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, treating these issues is often a initial approach toward sexual wellness.

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness.

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

Testosterone is also sometimes prescribed off-label to treat low libido 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 start with partnership dynamics and closeness.

“I would have no problem prescribing 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.

Other suggestions for increasing sexual desire are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “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 aroused, and ultimately to have a peak of sexual pleasure.”