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The federal agency broadened the authorized use of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to age 65.

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

The drug was first approved by the FDA in 2015, following a lengthy and contentious review process.

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 its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the maker of Addyi commended the FDA’s move to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Other specialists in female health voiced approval for the regulatory move.

“I had few tools for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

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

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, scientists observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The studies, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had reservations.

“This research don’t seem 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 speculated that this may have been part of the reason why Addyi was not initially cleared for older females.

“Patients have experienced adverse reactions like the fainting spells 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 broader approval was capped at age 65.

“It's unclear if that has to do with the intricacies of the medication. 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 easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

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

“I believe it will benefit this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted.

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

Women after menopause navigate a wide variety of changes that can affect libido. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to address low libido in females, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be considered. Conversations about libido 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.

Other suggestions for increasing libido are:

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

“You have to take an entire whole body approach to sexuality and this life stage in older age,” 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 climax of sexual pleasure.”