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The Food and Drug Administration (FDA) widened the indication of a oral treatment to address low libido in females to include women after menopause up to age 65.

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

The drug was originally authorized by the FDA in 2015, following a protracted and controversial review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of flibanserin praised the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be crucial to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not substantial. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it gets its informal name.

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

Nevertheless, scientists noted improvements in aspects of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major advocacy campaign.

Addyi carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

The label advises allowing a two-hour gap after consuming alcohol before taking 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 interactions of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The research, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

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

“There have been side effects like the syncopal episodes and lightheadedness 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 65 years of age.

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, 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 Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for low desire to a new population of women who may benefit.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

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

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

Postmenopausal females experience a broad range of symptoms that can affect sexual desire. Menopausal symptoms encompass:

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

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

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly vaginal 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 apprehensive about it and to view it as a viable choice.

Testosterone is also occasionally prescribed off-label to address reduced desire in females, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable 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 libido are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of orgasm.”