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The federal agency broadened the authorized use of a oral treatment to treat low libido in women to now encompass women after menopause up to age 65.

Before the announcement, the medication, flibanserin (Addyi), was solely authorized to address low sexual desire in women of reproductive age.

Flibanserin was originally authorized by the FDA in 2015, following a long and debated evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

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

The chief executive of the maker of flibanserin commended the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Other specialists in female health were supportive for the regulatory move.

“There was nothing for me to prescribe 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 crucial to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “quite reasonable” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

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

The drug was initially researched as an antidepressant but was found to be lacking during initial trials.

Nevertheless, scientists noted positive changes in aspects of libido and arousal 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 HSDD, following further studies and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before using Addyi to reduce the risk of syncope. If a person consumes several drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually prompted the maker to fund further research examining the combination. The studies, which were limited in size, showed no increased danger of syncope. But medical professionals had concerns.

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

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

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

Another doctor expressed uncertainty about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. Reviewing 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 easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD to a different group of females who may benefit.

“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 consulted all agreed that the female libido is complex and multifaceted.

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

Women after menopause navigate a wide variety of changes that can impact sexual desire. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy 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 “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a treatment option.

Androgen therapy is also sometimes used without formal approval to treat reduced desire in females, although it is not officially approved for it.

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

“I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing sexual desire include:

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

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “This involves understanding 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 peak of sexual pleasure.”