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U.S. regulators widened the indication of a oral treatment to treat low libido in women to now encompass women after menopause up to 65 years old.

Before the recent news, the medication, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

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

The chief executive of the maker of Addyi commended the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health were supportive for the decision.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval 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 news outlets that the decision was “understandable” given the available data.

Although supportive, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was originally developed as an medication for depression but was found to be lacking during early studies.

However, scientists observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

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

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

The label recommends waiting at least two hours after drinking before taking the drug to reduce the chance of syncope. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually led the maker to fund further research investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns.

“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 initially cleared for older females.

“Patients have experienced side effects like the syncopal episodes and lightheadedness 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 things like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the complexity of the medication. 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 prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a different group of women who may benefit.

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

But it is not a magic bullet. In fact, the experts interviewed all agreed that the female libido is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

Women after menopause navigate a wide variety of symptoms that can affect sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these symptoms is often a first step toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

Testosterone is also occasionally prescribed off-label to treat reduced desire in females, although it is not indicated for it.

But besides medication, experts say that personal habits should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing Addyi 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.

Additional recommendations for boosting sexual desire include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause 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 aroused, and ultimately to have a climax of sexual pleasure.”