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The federal agency expanded its approval of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to the age of sixty-five.

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

Flibanserin was originally authorized by the FDA in 2015, following a lengthy and contentious review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s action to expand the drug’s approval, calling it a “milestone” in advancing and focusing on female sexual health.

Additional OB-GYNs voiced approval for the decision.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be significant to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the placebo, but the extent of the improvement is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has little in common with the drug from which it gets its informal name.

The drug was initially researched as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, researchers noted positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label recommends waiting at least two hours after drinking before using Addyi to reduce the chance of syncope. If a person has three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund additional studies examining the combination. The research, which were limited in size, showed no increased danger of syncope. But experts had concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

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

“Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. 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 easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a different group of females who may find help.

“I believe it will serve this population better as long as they have no other medical problems,” said an specialist.

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

So addressing low desire 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:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

According to one expert, treating these issues is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She hopes 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 viable choice.

Androgen therapy is also sometimes used without formal approval to address low libido in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable 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.

Other recommendations for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “That means 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.”