U.S. Food and Drug Administration Grants Approval to Addyi, a Libido-Enhancing Treatment for Women After Menopause

U.S. regulators broadened the authorized use of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

Before the announcement, the medication, Addyi (flibanserin), was solely authorized to address low sexual desire in premenopausal females.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

Other women’s health experts were supportive for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal 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 professor of obstetrics and gynecology told reporters that the decision was “understandable” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

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

Nevertheless, scientists noted positive changes in aspects of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

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

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

The label advises waiting at least two hours after drinking before taking the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the maker to fund further research investigating the interaction. The research, which were limited in size, showed no increased danger of syncope. But medical professionals had reservations.

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

An OB-GYN speculated that this may have been part of the reason why Addyi was not originally approved for older females.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed confusion about why the broader approval was limited 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 easier information sheet because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

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

“I believe it will serve this demographic better as long as they have no other medical problems,” said an specialist.

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

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a wide variety of symptoms that can impact sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, treating these issues is often a first step toward improved intimacy.

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

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

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to consider 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 besides medication, doctors say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem prescribing flibanserin 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 recommendations for boosting sexual desire include:

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

“It requires an entire whole body approach to sexual health and this life stage in later life,” said an OB-GYN. “This involves 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.”