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U.S. regulators expanded its approval of a once-a-day medication to manage low libido in females to now encompass postmenopausal women up to age 65.

Prior to this week's decision, the medication, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

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

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s action to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on 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 premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to address women after menopause 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 decision was “understandable” given the available data.

While in favor, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, 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 gets its informal name.

The drug was first created as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, researchers observed positive changes 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 approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

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

The label recommends waiting at least two hours after drinking before using the drug to reduce the risk of fainting. If a person has several drinks on a given day, the label advises skipping the dose entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the maker to fund additional studies examining the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had concerns.

“These studies aren't 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 suggested that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at age 65.

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a new population of females who may find help.

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

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

Postmenopausal females navigate a wide variety of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• 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 first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

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 personal habits should also be factored in. Conversations about libido almost always start with relationships and intimacy.

“I am comfortable recommending Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting libido include:

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

“It requires an entire whole body approach to sexual health and this life stage 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.”