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

Before the recent news, the medication, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in women of reproductive age.

The drug was initially cleared by the FDA in 2015, following a lengthy and contentious evaluation period.

The FDA previously rejected 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 concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

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

“There was nothing for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “understandable” given the existing research.

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 improvement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is often called “female Viagra,” has significant differences with the medication from which it gets its informal name.

This medication was originally developed as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, scientists observed positive changes in measures of sexual function and redirected efforts to the drug’s potential 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 lobbying effort.

The medication carries a serious safety warning for serious side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to minimize the chance of syncope. If a person has several drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the maker to fund further research examining the combination. The studies, which were limited in size, showed no additional risk of syncope. But medical professionals had concerns.

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

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

“Patients have experienced adverse reactions 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 sensitive 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, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Despite these risks, Addyi could still broaden treatment options for HSDD to a new population of women who may find help.

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

But it is not a simple solution. In fact, the experts 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.

Women after menopause navigate a broad range of symptoms that can impact libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

According to one expert, treating these issues is often a initial approach toward sexual wellness.

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

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

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

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

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about libido almost always start with relationships and intimacy.

“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 include:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• practicing extended foreplay
• using sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an expert. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”