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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to 65 years old.

Prior to this week's decision, the medication, Addyi (flibanserin), was solely authorized to treat low sexual desire in premenopausal females.

Flibanserin was initially cleared by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s decision to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

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

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

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

While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug daily and not getting bang for your buck?”

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

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

This medication was first created as an antidepressant but was found to be lacking during early studies.

However, researchers noted improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had reservations.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause why the drug was not initially cleared for older females.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness 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 things like that,” she said.

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

“I don’t know if that has to do with the intricacies 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 clearer instructions because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a new population of women who may find help.

“I do think 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 experts interviewed all agreed that the female libido is complex and multifaceted.

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

Women after menopause navigate a broad range of changes that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

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

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

She hopes that the FDA’s recent removal 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 indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing flibanserin after discussing it 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 are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “This involves understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”