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U.S. regulators broadened the authorized use of a oral treatment to treat low libido in women to cover postmenopausal women up to age 65.

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

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

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

The founder and CEO of the maker of Addyi praised the FDA’s action to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Additional OB-GYNs 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 obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be crucial to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “understandable” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was considered unsuccessful during initial trials.

However, scientists observed improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a treatment for low libido.

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

Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before using Addyi to reduce the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the maker to fund additional studies examining the combination. The studies, which were small in scale, showed no increased danger of fainting. But medical professionals had reservations.

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

An gynecologist speculated that this may have been part of the reason why the drug was not initially cleared for older females.

“There have been side effects like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a new population of females who may benefit.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a simple solution. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted.

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can affect libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, managing these symptoms is often a initial approach toward sexual wellness.

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

The expert recommended both vaginal estrogen 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 “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

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

But besides medication, doctors say that lifestyle should also be considered. Conversations about libido almost always start with relationships and intimacy.

“I am comfortable recommending 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.

Other recommendations for boosting libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• 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 intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”