🔗 Share this article

The Food and Drug Administration (FDA) widened the indication of a daily pill to treat low libido in females to cover women after menopause up to age 65.

Prior to the recent news, the pill, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication 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 separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs voiced approval for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be significant to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the available data.

Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.

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

However, scientists observed positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label recommends allowing a two-hour gap after drinking before using Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually prompted the maker to fund additional studies examining the interaction. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

“This research don’t seem very persuasive to me. They are a beginning, 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 cause why Addyi was not initially cleared for older females.

“There have been side effects like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. 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.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a different group of women who may benefit.

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

But it is not a quick fix. In fact, the specialists consulted all agreed that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

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

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, managing these issues is often a first step toward improved intimacy.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to view it as a viable choice.

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

But besides medication, experts say that lifestyle should also be considered. Conversations about libido almost always start with relationships and intimacy.

“I am comfortable prescribing flibanserin 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.

Additional recommendations for boosting sexual desire are:

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

“You have to take an comprehensive, holistic strategy to sexual health and this life stage 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 excited, and ultimately to have a climax of orgasm.”