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The Food and Drug Administration (FDA) widened the indication of a daily pill to manage low libido in females to now encompass women after menopause up to 65 years old.

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

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Other women’s health experts were supportive for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists noted positive changes in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends allowing a two-hour gap after drinking before using the drug to reduce the risk of syncope. If a person has several drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the combination. The studies, which were limited in size, showed no increased danger of syncope. But experts had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale 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 Addyi was not initially cleared for postmenopausal women.

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

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

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a different group of women who may find help.

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

But it is not a magic bullet. In fact, the specialists consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing HSDD means considering everything from relationship dynamics to shifts in hormone levels.

Women after menopause navigate a wide variety of symptoms that can impact sexual desire. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, treating these symptoms is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Androgen therapy is also sometimes prescribed off-label to address low libido in women, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.

“I am comfortable 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 recommendations for boosting libido include:

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

“You have to take an entire whole body approach to sexuality and this life stage in older age,” said an OB-GYN. “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 sexual pleasure.”