FDA Approves Addyi, a Libido-Enhancing Drug for Postmenopausal

U.S. regulators broadened the authorized use of a oral treatment to treat low libido in females to cover postmenopausal women up to age 65.

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

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

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

The chief executive of the maker of Addyi praised the FDA’s action to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Other OB-GYNs were supportive for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “logical” given the existing research.

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the improvement is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

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

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

Nevertheless, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

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

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

Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the combination. The studies, which were small in scale, showed no increased danger of fainting. But experts had reservations.

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

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

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

Another doctor expressed confusion about why the expanded indication was limited 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, 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.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a different group of women who may find help.

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

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

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

Postmenopausal females navigate a broad range of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to treat 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 begin by focusing on relationships and intimacy.

“I am comfortable recommending Addyi after discussing it 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 are:

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

“It requires an comprehensive, holistic strategy to sexual health and menopause 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 climax of sexual pleasure.”