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U.S. regulators widened the indication of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to age 65.

Prior to this week's decision, the medication, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.

This medication was initially cleared by the FDA in two thousand fifteen, 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 FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional women’s health experts voiced approval for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the improvement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it gets its informal name.

This medication was initially researched as an antidepressant but was found to be lacking during initial trials.

Nevertheless, researchers noted positive changes in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following additional research and a considerable lobbying effort.

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

Official guidance recommends waiting at least two hours after drinking before using Addyi to minimize the chance of syncope. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had reservations.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a health research president stated.

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

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

Another doctor echoed confusion about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for low desire to a different group of women who may find help.

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

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of changes that can impact sexual desire. Symptoms of menopause include:

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

According to one expert, managing these issues is often a first step toward sexual wellness.

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

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

She expressed hope that the FDA’s recent removal of its “serious” 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 prescribed off-label to address reduced desire in females, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”