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The Food and Drug Administration (FDA) widened the indication of a oral treatment to treat low libido in females to now encompass women after menopause up to 65 years old.

Prior to the recent news, the pill, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

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

The founder and CEO of the maker of flibanserin praised the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

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

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be significant to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “logical” given the available data.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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.

The drug was first created as an antidepressant but was deemed ineffective during initial trials.

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

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

The medication carries a serious safety warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

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

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund further research examining the interaction. The research, which were limited in size, showed no additional risk of syncope. But experts had reservations.

“This research don’t seem very convincing 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 OB-GYN suggested that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

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

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

Treating Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a different group of females who may find help.

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

But it is not a quick fix. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors.

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

Postmenopausal females navigate a broad range of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, managing these issues is often a initial approach toward improved intimacy.

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a viable choice.

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

But besides medication, doctors say that personal habits should also be factored in. Conversations about libido almost always start with partnership dynamics and closeness.

“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.

Other suggestions for boosting sexual desire include:

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

“It requires an comprehensive, holistic strategy to sexual health and this life stage in later life,” 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.”