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

The federal agency widened the indication of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to age 65.

Prior to the announcement, the medication, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s action to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Other OB-GYNs expressed support for the decision.

“I had few tools for me to prescribe because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be crucial to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

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

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

What is Addyi, the ‘Women's Desire Pill’?

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

This medication was initially researched as an antidepressant but was deemed ineffective during early studies.

Nevertheless, researchers noted 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 approved in 2015 to treat HSDD, following additional research and a major advocacy campaign.

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

The label recommends allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the label advises not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the maker to fund further research examining the interaction. The research, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“This research don’t seem very persuasive 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 gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

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

Another doctor expressed uncertainty about why the broader approval was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden therapeutic choices 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 health issues,” said an OB-GYN.

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

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

Postmenopausal females navigate a broad range of changes that can impact libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a first step toward sexual wellness.

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

The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to treat the effects 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 consider it as a treatment option.

Androgen therapy is also sometimes used without formal approval to treat reduced desire in females, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be considered. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing 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.

Additional suggestions for boosting sexual desire include:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “That means knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”