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The Food and Drug Administration (FDA) widened the indication of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to age 65.

Before the recent news, the medication, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was originally authorized by the FDA in 2015, following a lengthy and contentious review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s action to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional specialists in female health voiced approval for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be crucial 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 “understandable” given the existing research.

Although supportive, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

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

The drug was first created as an medication for depression but was found to be lacking during initial trials.

However, scientists observed improvements in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following further studies and a major advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

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

Assertions about the interactions of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the combination. The studies, which were small in scale, showed no additional risk of fainting. But medical professionals had reservations.

“These studies don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

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

“Patients have experienced side effects like the syncopal episodes 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 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 complexity of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

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

“I do think it will serve this population better as long as they have no other health issues,” said an specialist.

But it is not a quick fix. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a broad range of symptoms that can impact libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less concerned about it and to view it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to address low libido in females, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions 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 psychosocial issues going on,” she said.

Other suggestions for boosting sexual desire are:

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

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an expert. “That means knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”