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The federal agency broadened the authorized use of a oral treatment to manage low libido in females to cover women after menopause up to the age of sixty-five.

Prior to this week's decision, the medication, Addyi (flibanserin), was solely authorized to address low sexual desire in premenopausal females.

Flibanserin was originally authorized 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 FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of Addyi commended the FDA’s action to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional women’s health experts were supportive for the decision.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the available data.

While in favor, the expert was measured 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 seeing a major effect?”

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

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

This medication was originally developed as an antidepressant but was considered unsuccessful 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 low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a major advocacy campaign.

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

Official guidance advises allowing a two-hour gap after consuming alcohol before taking the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises skipping the dose entirely.

Claims about the interactions of mixing the drug with drinking eventually led the maker to fund further research investigating the interaction. The studies, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had reservations.

“This research aren't very convincing 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 speculated that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.

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

Another doctor echoed confusion about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. 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.

Addressing Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand treatment options for low desire to a new population of females who may find help.

“I believe it will serve this population better as long as they have no other medical problems,” 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 treating low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a broad range of symptoms that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

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

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

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

Androgen therapy is also sometimes used without formal approval to treat low libido in women, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

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

Additional suggestions for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “This involves knowing 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.”