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

Before this week's decision, the drug, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

This medication was first approved by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of flibanserin praised the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Other women’s health experts voiced approval for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval was “logical” given the available data.

While in favor, 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 dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Addyi, 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.

This medication was first created as an antidepressant but was deemed ineffective during early studies.

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

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

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label advises waiting at least two hours after drinking before using the drug to minimize the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were limited in size, showed no increased danger of fainting. But experts had concerns.

“These studies don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for older females.

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

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

“It's unclear 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 cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for low desire to a different group of women who may find help.

“I do think it will benefit this population 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 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.

Postmenopausal females experience a broad range of symptoms that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, treating these issues is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the effects of menopause, particularly dryness.

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

Testosterone is also sometimes prescribed off-label to address reduced desire in females, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be factored in. Discussions 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.

Other suggestions for increasing sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “This involves 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 climax of sexual pleasure.”