FDA Grants Approval to Addyi, a Libido-Enhancing Drug for Postmenopausal

The federal agency widened the indication of a oral treatment to address low libido in females to include women after menopause up to the age of sixty-five.

Before this week's decision, the medication, Addyi (flibanserin), was only approved to treat low sexual desire in women of reproductive age.

The drug was first approved by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The founder and CEO of the maker of Addyi applauded the FDA’s move to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other women’s health experts voiced approval for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was initially researched as an medication for depression but was found to be lacking during early studies.

However, researchers noted positive changes in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label recommends waiting at least two hours after drinking before using Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, 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 health research president stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

Another doctor expressed confusion 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. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a different group of females who may benefit.

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

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

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

Women after menopause experience a wide variety of symptoms that can affect sexual desire. Symptoms of menopause include:

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

According to one expert, managing these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my first question 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 dryness.

She expressed hope that the regulatory decision to lift 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 reduced desire in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about libido almost always start with partnership dynamics and closeness.

“I am comfortable recommending flibanserin 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 increasing sexual desire are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• incorporating vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in older age,” said an expert. “This involves understanding 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 climax of orgasm.”