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The federal agency expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to 65 years old.

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

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of flibanserin praised the FDA’s decision to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs expressed support for the regulatory move.

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

A professor of obstetrics and gynecology told news outlets that the decision was “logical” given the available data.

Although supportive, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the improvement is not dramatic. Does it justify taking a drug daily and not getting bang for your buck?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the medication from which it draws its nickname.

The drug was initially researched as an antidepressant but was found to be lacking during initial trials.

However, scientists noted improvements in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for low libido.

Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after drinking before using the drug to minimize the risk of syncope. If a person consumes several drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The research, which were small in scale, showed no increased danger of fainting. But medical professionals had concerns.

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

An OB-GYN speculated that this may have been part of the reason why Addyi was not initially cleared for older females.

“There have been adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was limited at 65 years of age.

“It's unclear 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 clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a new population of females who may benefit.

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

But it is not a quick fix. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

So treating low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can affect libido. Menopausal symptoms encompass:

• sudden feelings of heat
• 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.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope 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 viable choice.

Androgen therapy is also occasionally used without formal approval to address reduced desire in females, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem prescribing flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• practicing extended foreplay
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “That means knowing how your body works, your anatomy, 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.”