- 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.”
- It’s recommended to avoid taking Addyi within two hours of consuming alcohol to avoid potential interactions and dangerous side effects.
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.
Prior to the announcement this week, the pill, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.
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.
“The studies showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not overwhelming,” Minkin said.
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.
Addyi carries a warning for potential side effects when combined with alcohol, including low blood pressure (hypotension) and fainting (syncope).
The label recommends waiting at least two hours after drinking alcohol 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, though small in scale, demonstrated no additional risk of syncope.
“There have been side effects like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of [Addyi] treatment,” said Darwanna Todd, MD, an OB-GYN at the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas.
“When you get older, you become more sensitive to things like that,” she told Healthline.
Addyi could 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’s not a magic bullet. The experts interviewed by Healthline acknowledged that the female libido is complex and multifaceted. 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.
Minkin recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly vaginal dryness.
She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.
Testosterone is also sometimes prescribed off-label to treat low libido in females, although it is not indicated for it.
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.”