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U.S. regulators expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to 65 years old.

Prior to the recent news, the medication, Addyi (flibanserin), was only approved to address low sexual desire in women of reproductive age.

The drug was originally authorized by the FDA in 2015, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

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

The founder and CEO of the maker of flibanserin applauded the FDA’s decision to expand the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

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

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be crucial to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

While in favor, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding 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 first created as an antidepressant but was found to be lacking during early studies.

However, researchers observed positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before using Addyi to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

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

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

An OB-GYN speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced side effects 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 older, you become more susceptible to effects like that,” she said.

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

“It's unclear if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a different group of women who may find help.

“I do think it will serve this population better as long as they have no other health issues,” said an specialist.

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

So addressing HSDD means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a wide variety of symptoms that can impact libido. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

“If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

She expressed hope 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 treatment option.

Androgen therapy is also sometimes used without formal approval to address low libido in women, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing flibanserin 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 recommendations for increasing libido include:

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

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an expert. “This involves understanding how your body works, your anatomy, 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.”