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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to address low libido in females to cover women after menopause up to the age of sixty-five.

Before this week's decision, the drug, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in women of reproductive age.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the maker of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

While in favor, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

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

This medication was initially researched as an medication for depression but was found to be lacking during initial trials.

However, scientists observed improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before using the drug to minimize the chance of fainting. If a person has three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the maker to fund additional studies investigating the combination. The studies, which were small in scale, showed no additional risk of syncope. But experts 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 gynecologist suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“Patients have experienced side effects like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was capped at age 65.

“I don’t know 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 easier information sheet because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

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

“I do think it will benefit this demographic 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 all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females experience a wide variety of changes that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a viable choice.

Testosterone is also occasionally prescribed off-label to treat reduced desire in females, although it is not indicated for it.

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

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting sexual desire include:

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

“It requires an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “That means understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”