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The federal agency broadened the authorized use of a oral treatment to treat low libido in females to include postmenopausal women up to age 65.

Before this week's decision, the drug, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) 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 distinct instances, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s move to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional specialists in female health voiced approval for the decision.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be significant to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the clinical evidence.

While in favor, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not overwhelming. Does it justify taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

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

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

However, scientists observed positive changes in measures of sexual function and redirected efforts to the drug’s possible use 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 major advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before taking the drug to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the combination. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had concerns.

“This research aren't very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An gynecologist speculated that this may have been part of the reason why Addyi was not originally approved for older females.

“There have been side effects like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at age 65.

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

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a different group of females who may find help.

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

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a broad range of changes that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option.

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

But in addition to drugs, doctors say that personal habits should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing sexual desire are:

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

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “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 excited, and ultimately to have a climax of sexual pleasure.”