U.S. Food and Drug Administration Clears Addyi, a Desire-Boosting Treatment for Women After Menopause

The federal agency widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to age 65.

Prior to the recent news, the medication, Addyi (flibanserin), was solely authorized to address low sexual desire in premenopausal females.

This medication was first approved by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of Addyi praised the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Other OB-GYNs were supportive for the decision.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be crucial to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

The drug was first created as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, scientists observed positive changes in aspects of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

The medication carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

The label advises waiting at least two hours after consuming alcohol before using Addyi to reduce the risk of syncope. If a person consumes several drinks on a given day, the instructions recommends skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the interaction. The research, which were limited in size, showed no additional risk of syncope. But medical professionals had concerns.

“This research aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president 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 side effects like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a different group of women who may benefit.

“I do think it will serve this demographic better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a wide variety of symptoms that can affect libido. Symptoms of menopause include:

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

According to one expert, managing these symptoms is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, 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 treatments to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also occasionally used without formal approval to address low libido in females, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about libido almost always start with partnership dynamics and closeness.

“I am comfortable prescribing Addyi 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 suggestions for increasing sexual desire are:

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

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “This involves 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 orgasm.”