🔗 Share this article

The federal agency broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to 65 years old.

Prior to this week's decision, the drug, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was originally authorized by the FDA in 2015, 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 both cases, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s decision to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Other specialists in female health were supportive for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be crucial to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “logical” given the clinical evidence.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was initially researched as an medication for depression but was deemed ineffective during early studies.

However, researchers noted positive changes in measures of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

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

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance recommends allowing a two-hour gap after drinking before taking Addyi to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually prompted 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 concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a health research president stated.

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

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed 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, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for HSDD to a new population of females who may benefit.

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

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

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

Women after menopause experience a wide variety of symptoms that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these symptoms is often a first step toward improved intimacy.

“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 hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to treat low libido in females, although it is not officially approved for it.

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

“I would have no problem recommending Addyi after discussing it 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
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an expert. “That means knowing how your body works, your anatomy, 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 orgasm.”