FDA Clears Addyi, a Desire-Boosting Medication for Women After Menopause

U.S. regulators expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to the age of sixty-five.

Before the announcement, the drug, Addyi (flibanserin), was solely authorized to treat low sexual desire in premenopausal females.

This medication was first approved by the FDA in 2015, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of Addyi applauded the FDA’s move to expand the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Other OB-GYNs were supportive for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “logical” given the existing research.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

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

This medication was first created as an medication for depression 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 therapy for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

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

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to minimize the risk of syncope. If a person consumes several drinks on a single occasion, the instructions advises skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were small in scale, showed no additional risk of syncope. But experts had concerns.

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

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“There have been side effects like the syncopal episodes 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 susceptible 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 complexity of the drug. 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 prescribing,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a different group of females who may find help.

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

But it is not a magic bullet. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a wide variety of changes that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

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

Testosterone is also sometimes used without formal approval to treat low libido in women, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be considered. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for boosting sexual desire include:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an expert. “That means understanding 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 sexual pleasure.”