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The federal agency expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

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

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

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the maker of Addyi applauded the FDA’s action to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional women’s health experts expressed support for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be significant 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 “understandable” given the clinical evidence.

While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

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

This medication was initially researched as an medication for depression but was considered unsuccessful during initial trials.

However, scientists observed improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

The medication carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after drinking before taking Addyi to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the interaction. The research, which were small in scale, showed no additional risk of fainting. But medical professionals had concerns.

“This research don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

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

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

Another doctor echoed uncertainty about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the complexity of the drug. If you take 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 Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still broaden treatment options 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 medical problems,” said an specialist.

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.

So treating HSDD means considering everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a broad range of changes that can impact libido. Menopausal symptoms encompass:

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

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

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

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms 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 viable choice.

Testosterone is also sometimes used without formal approval to address reduced desire in women, although it is not officially approved for it.

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

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “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 excited, and ultimately to have a peak of sexual pleasure.”