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U.S. regulators broadened the authorized use of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to 65 years old.

Before the announcement, the medication, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication 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 separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.

Today, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s move to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Other women’s health experts expressed support for the decision.

“There was nothing 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 group of women could be crucial to help women after menopause who wish to engage in 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 clinical evidence.

Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the enhancement 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 often called “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was originally developed as an antidepressant but was found to be lacking 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 diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label advises allowing a two-hour gap after consuming alcohol before using the drug to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

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

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

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

“There have been adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage 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 capped at age 65.

“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.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a new population of females who may find help.

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

But it is not a magic bullet. In fact, the experts 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 hormonal changes.

Postmenopausal females experience a wide variety of symptoms that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly vaginal dryness.

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

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

But besides medication, experts say that personal habits should also be factored in. Discussions about libido 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 encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing sexual desire include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage in older age,” said an expert. “This involves knowing 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.”