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The federal agency widened the indication of a once-a-day medication to manage low libido in women to now encompass postmenopausal women up to age 65.

Prior to the announcement, the pill, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was originally authorized by the FDA in 2015, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the maker of flibanserin commended the FDA’s action to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Other women’s health experts were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “understandable” given the existing research.

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the benefit is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

The drug was originally developed as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, scientists noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after drinking before taking the drug to reduce the risk of fainting. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund further research examining the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

“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 public health expert stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. 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. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for HSDD 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 magic bullet. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

So addressing HSDD means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a broad range of symptoms that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward improved intimacy.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both topical estrogen therapy 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 “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice.

Androgen therapy 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 lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem recommending flibanserin 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.

Additional suggestions for boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “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 peak of orgasm.”