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The federal agency broadened the authorized use of a oral treatment to address low libido in females to now encompass postmenopausal women up to age 65.

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

This medication was initially cleared by the FDA in 2015, following a long and debated review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, 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 Addyi commended the FDA’s action to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the clinical evidence.

Although supportive, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was found to be lacking during early studies.

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

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a major advocacy campaign.

Addyi carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person consumes several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the combination. The research, which were limited in size, showed no additional risk of fainting. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the fainting spells and lightheadedness 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 uncertainty about why the broader approval was limited 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, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a new population of females who may benefit.

“I believe it will benefit this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a simple solution. In fact, the specialists interviewed all agreed that the women's sexual desire is influenced by many factors.

So addressing low desire means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause experience a broad range of symptoms that can impact libido. Menopausal symptoms 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 initial approach toward sexual wellness.

“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 vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly vaginal dryness.

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

Testosterone is also occasionally prescribed off-label to address reduced desire in women, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting sexual desire are:

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

“You have to take an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “This involves knowing 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 climax of sexual pleasure.”