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U.S. regulators expanded its approval of a oral treatment to treat low libido in females to cover postmenopausal women up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was first approved by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of flibanserin praised 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 were supportive for the decision.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important 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 reporters that the decision was “quite reasonable” given the available data.

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it draws its nickname.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, researchers noted positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy 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.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually led the maker to fund additional studies investigating the combination. The studies, which were small in scale, showed no additional risk of syncope. But experts had concerns.

“This research aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

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

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed uncertainty about why the broader approval was limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

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

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

But it is not a quick fix. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a wide variety of changes that can affect libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

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

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

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat low libido in women, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.

“I would have no problem recommending Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing libido are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexuality 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 excited, and ultimately to have a climax of orgasm.”