- The FDA expanded its approval of Addyi, a pill to treat low libido in women, to include postmenopausal women up to age 65.
- The approval will open up new treatment options for older women, but experts caution that treating low libido requires a “whole body approach.”
- Addyi is known to have potentially dangerous interactions with alcohol that may lead to loss of consciousness, so abstinence from alcohol is recommended.
The Food and Drug Administration (FDA) expanded its approval of a daily pill to treat low libido in females to include postmenopausal women up to age 65.
The drug was first approved 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 2013. In both cases, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.
Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.
Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, the maker of Addyi, praised the FDA’s decision to expand the drug’s approval in a press release, calling it a “milestone” in understanding and prioritizing female sexual health.
Other women’s health experts expressed support for the decision.
“There was nothing really for me to prescribe because everything was for women who were menstrual and not menopausal,” said G. Thomas Ruiz, MD, an OB-GYN at MemorialCare Orange Coast Medical Center in Fountain Valley, CA. “Getting the FDA approval for this patient population could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”
Mary Jane Minkin, MD, a clinical professor in the department of obstetrics, gynecology, and reproductive sciences at Yale University, told Healthline that the approval was “quite reasonable” given the available data.
Although supportive of the move, Minkin was measured in her assessment of the drug: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”
Addyi, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it draws its nickname.
The drug was originally developed as an antidepressant but was deemed ineffective during early studies.
However, researchers observed improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.
After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable lobbying effort by Even the Score, a group linked to Sprout Pharmaceuticals.
The label recommends waiting at least two hours after drinking before taking Addyi to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.
Claims about the effects of combining Addyi and alcohol eventually prompted Sprout Pharmaceuticals to fund additional studies examining the interaction. The studies, which were small in scale, demonstrated no additional risk of syncope. But experts had reservations.
“These studies don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” Diana Zuckerman, PhD, president of the National Center for Health Research, told Healthline in 2019.
Darwanna Todd, MD, an OB-GYN at the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas, speculated that this may have been part of the reason why Addyi was not originally approved for older females.
“There have been side effects like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.
Ruiz echoed 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 medication. If you take a list of the dos and don’ts when you can take alcohol, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.
Despite these risks, Addyi could still expand treatment options for HSDD to a new population of females who may benefit.
“I do think it will serve this population better as long as they have no other health issues,” said Todd.
But it is not a magic bullet. In fact, the experts interviewed for this story universally acknowledged that the female libido is complex and multifaceted.
So addressing HSDD means engaging with everything from relationship dynamics to hormonal changes.
Postmenopausal females navigate a wide variety of symptoms that can affect sexual desire. Symptoms of menopause include:
According to Minkin, treating these symptoms is often a first step toward sexual wellness.
“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.
But besides medication, experts say that lifestyle should also be factored in. Minkin told Healthline that conversations about libido almost always begin by focusing on relationships and intimacy.
“I would have no problem prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.
Other recommendations for increasing libido include:
- getting more sleep
- exercising
- staying active
- using over-the-counter lubricants
- engaging in extended foreplay
- using vibrators or dilators
“You have to take an entire whole body approach to sexuality and menopause in older age,” said Ruiz.
“That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”
