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U.S. regulators widened the indication of a once-a-day medication to manage low libido in women to include women after menopause up to 65 years old.

Prior to the announcement, the pill, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

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

Today, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s decision to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Other specialists in female health were supportive for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

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

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was originally developed as an medication for depression but was found to be lacking during early studies.

Nevertheless, researchers noted positive changes in measures of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance recommends allowing a two-hour gap after drinking before taking the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the combination. The studies, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

“This research don’t seem very convincing 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 suggested that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells and lightheadedness 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 expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. 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 clearer instructions because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still broaden treatment options for HSDD to a new population of females 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 quick fix. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

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

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

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, treating these issues is often a first step 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 suggested both vaginal estrogen and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to treat reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for boosting libido are:

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

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “This involves knowing how your body works, your anatomy, 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 orgasm.”