U.S. Food and Drug Administration Grants Approval to Addyi, a Desire-Boosting Medication for Women After Menopause

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

Before the recent news, the drug, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other women’s health experts were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was initially researched as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, scientists noted improvements in aspects of libido and arousal and shifted focus 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 potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label advises waiting at least two hours after drinking before taking Addyi to minimize the chance of fainting. If a person has three or more alcoholic drinks on a given day, the label advises skipping the dose entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies examining the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“This research aren't very persuasive 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 reason why the drug was not initially cleared for older females.

“There have been adverse reactions like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped 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, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a new population of women who may benefit.

“I believe it will serve this population 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 female libido is influenced by many factors.

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

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

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“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 suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly dryness.

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

Androgen therapy is also sometimes used without formal approval to address low libido in women, although it is not officially approved for it.

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

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing libido are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and this life stage in older age,” said an expert. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”