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U.S. regulators expanded its approval of a daily pill to treat low libido in females to include women after menopause up to 65 years old.

Prior to this week's decision, the pill, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s move to expand the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Other OB-GYNs expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be significant to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the existing research.

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

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

The drug was first created as an medication for depression but was found to be lacking during initial trials.

However, researchers noted improvements in aspects 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 HSDD, following further studies and a considerable advocacy campaign.

The medication carries a boxed (“black box”) 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 drinking before taking the drug to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the interaction. The studies, which were limited in size, demonstrated no increased danger of syncope. But experts had reservations.

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

An gynecologist 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 individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible 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 complexity of the drug. If you take 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 simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a new population of women who may find help.

“I believe it will benefit this population better as long as they have no other health issues,” said an OB-GYN.

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

So addressing low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause navigate a broad range of symptoms that can impact sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes prescribed off-label 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 factored in. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage in older age,” said an expert. “This involves 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 orgasm.”