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The federal agency widened the indication of a oral treatment to address low libido in women to include postmenopausal women up to age 65.

Prior to the announcement, the pill, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s move to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs voiced approval for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be very important to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not substantial. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Addyi, which is often called “female Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was first created as an antidepressant but was considered unsuccessful during initial trials.

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

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before using the drug to reduce the risk of syncope. If a person consumes several drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the interactions of combining the drug with drinking eventually led the maker to fund further research examining the interaction. The research, which were small in scale, showed no increased danger of fainting. 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 are short-term,” 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 older females.

“There have been adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a different group of women who may benefit.

“I do think it will serve this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the female libido is complex and multifaceted.

So treating low desire means considering everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of changes that can affect sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

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

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, experts say that personal habits should also be factored in. Discussions about sexual desire almost always start with relationships and intimacy.

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

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