MDMA-Assisted Therapy Transformed Her Life. So Why Did the FDA Just Reject It?
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On Friday, the Food and Drug Administration (FDA) refused to approve midomafetamine (MDMA) for the treatment of post-traumatic stress disorder (PTSD), citing insufficient data. But Lykos Therapeutics, the maker of what would have been the first legal psychedelic medicine wasn’t the only one devastated by the ruling. Millions of women who are suffering from PTSD also lost out. Women are twice as likely as men to develop the condition, with an estimated 10% of women experiencing the disorder sometime in their lifetime.
Many experts were disappointed in the decision. MDMA “has been shown to be safe and effective in the right conditions,” says Sunil Aggarwal, M.D., Ph.D., a physician in Seattle, Washington, who had been hoping to soon prescribe the drug to his patients.
Instead, the FDA declined the drug application from Lykos Therapeutics and requested additional clinical trials, a process that could take years. This follows two large studies already completed, published in 2023 and 2021, that found three sessions of MDMA, along with accompanying psychotherapy before, during and after, significantly improves PTSD, in many cases to the point where symptoms can no longer be detected.
The FDA argued that most people who got the MDMA in the studies guessed they had — because its psychedelic effects are hard to mimic with a placebo — and this might have skewed the results. The agency also worried the company hadn’t sufficiently tracked the potential for abuse following treatment, a concern given that MDMA is widely used as a street drug under the names ecstasy and molly.
Still, the drug “could have at least been conditionally approved with required safety data collection and post-marketing studies,” Dr. Aggarwal says. “There are plenty of tools [the FDA could have used] to ensure a slow, cautious roll-out of this novel treatment.”
Lykos has said it will appeal the FDA’s decision.
If you or someone you know may be at risk for suicide, immediately seek help. You are not alone. Call the U.S. National Suicide Prevention Hotline at 800-273-TALK (8225), call 911 or call a friend or family member to stay with you until emergency medical personnel arrive to help you.
What is PTSD?
To understand why this FDA ruling is so important for those with PTSD, it's helpful to have a little background info about the condition. PTSD happens when an experience is so traumatic it constantly intrudes on the mind, via flashbacks, nightmares, memory issues, insomnia and the inability to go about your daily life — sometimes lasting for months or years.
We often think of PTSD as something that affects people in the military, and of course it does: Some 8,000 service members are discharged each year due to the disease. Along with depression, it is largely responsible for the 17 veterans who die by suicide every day.
But the condition also follows any number of traumas women experience throughout their lifetime, including sexual or other violence (about half of rape survivors develop PTSD, experts say), car accidents, surviving a fire or natural disaster, losing a loved one, and other life-altering events.
PTSD is difficult to treat
Getting access to MDMA-assisted therapy through a clinical trial transformed the life of Sehrish Sayani, a 36-year- old Los Angeles marketing executive. For more than a decade after her mother suddenly died when she was a young adult, Sayani suffered from fitful sleep, intense anxiety and the feeling she was always waiting for another shoe to drop.
Three sessions of the drug and accompanying therapy “brought down the curtains and let me see my experience for what it was,” Sayani says. This let her finally process her grief over her mother’s death that the PTSD had prevented her from doing. Since then, she’s been calm and happy and sleeps great.
MDMA-assisted therapy “gets below the symptom level issues to more of the root causes,” says Alan K. Davis, Ph.D., a social work researcher at Ohio State University and director of its Center for Psychedelic Drug Research and Education.
Currently available therapies help many women, of course. These include prolonged exposure, where you reexperience the trauma as a therapist guides you to stay grounded, and eye movement desensitization and reprocessing (EMDR), techniques that stimulate the brain as you recall the traumatic incident. Doctors also often prescribe antidepressants or anti-anxiety medicines.
But “current approved treatments don’t address feelings of disconnection and the complexity of the mental health challenges faced by people with PTSD,” Davis says, while MDMA does.
What to do if you have PTSD
In addition to seeking professional help, women with PTSD can take additional steps that experts say are effective, like meditating for 10 minutes a day, which rebuilds brain connections ruptured by trauma; eating a healthy Mediterranean diet rather than the comfort junk foods you may crave, to heal the GI tract linked to the nervous system; and seeking support from friends or other people who are also coping from traumas.
Experts are clear on what people shouldn’t do, though: You should not look for or use illegal MDMA on the street. Not only are those drugs not produced with quality ingredients like pharmaceuticals are, they are often adulterated with dangerous compounds.
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