FDA Approves Addyi, a Desire-Boosting Treatment for Postmenopausal

The federal agency widened the indication of a daily pill to treat low libido in females to cover women after menopause up to the age of sixty-five.

Before the announcement, the medication, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s action to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts were supportive 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 obstetrician-gynecologist. “Securing 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 approval was “understandable” given the available data.

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

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

Addyi, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was first created as an antidepressant but was considered unsuccessful during early studies.

However, scientists noted improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

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

Official guidance advises allowing a two-hour gap after drinking before using the drug to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund further research investigating the combination. The studies, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had reservations.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

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

“Patients have experienced side effects 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 things 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 intricacies of the medication. Reviewing 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 simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

“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 simple solution. In fact, the specialists interviewed all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females experience a wide variety of symptoms that can affect sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

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

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less concerned about it and to view it as a treatment option.

Testosterone is also occasionally used without formal approval to treat reduced desire in females, although it is not indicated for it.

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

“I am comfortable prescribing Addyi 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 increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

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