Summary: A Plus speaks to MAPS-sponsored MDMA researcher Michael Mithoefer, M.D., about the U.S. Food and Drug Administration (FDA) granting Breakthrough Therapy Designation (BTD) to MDMA for the treatment of posttraumatic stress disorder (PTSD). “One thing I’ve learned in 40-plus years of practicing medicine is that different people respond to different treatment,” explains Mithoefer. “I think it could bea very important addition to what we have to offer. We’ve had very big effects in people who have failed other treatments — both therapy and medication.”
Originally appearing here.
When I think of MDMA, I picture a common scene from college: a group of sweaty bodies, a dark, strobe-lit club, loud bass in your ears and intoxicated students chugging water in every direction. In the last few decades, ecstasy and Molly — the street form of MDMA — have become hugely popular amongst 20-somethings on college campuses and in certain music scenes. With that growing popularity has come the horror stories around overdoses, dehydration, and ecstasy being cut with other drugs.
Imagine my surprise when I learned that MDMA is moving from strobe-lit dance floors to sterile exam rooms. This week, the US Food and Drug Administration (FDA) announced that 3,4 methylenedioxymethamphetamine (or MDMA) is a “breakthrough therapy” in the treatment of PTSD. According to the FDA website, that status is only granted when “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement” over whatever is currently available.
Dr. Michael Mithoefer, a psychiatrist who is the medical monitor for the Phase 3 testing, told A Plus that the news proves the stigma around MDMA is not holding the FDA back.
“We’re taking it more as an acknowledgement of the science,” he said. “The breakthrough therapy indicates that they think this has a chance of being a significantly more effective treatment… it has the potential — in their judgment and ours — to provide a significantly better treatment.”
A driving force behind this development is the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), who A Plus reported on in May of 2016. At the time, the director of communications and marketing for MAPS, Brad Burge, told A Plus that he expected the FDA to approve MDMA trials for use in PTSD therapy as early as 2021. Clearly, this news means things are happening at a faster clip than they expected, but it’s still been a long time coming. MAPS has been testing MDMA since 1986 and had submitted its first protocol for approval to the FDA in 2001.
Previously, MDMA had been approved for testing on animals, then testing on healthy patients (Phase 1), and even advanced to Phase 2 testing, where it successfully improved patients with previous diagnosis. But this news will send MDMA into Phase 3 medical testing, one of the final steps towards getting FDA approval, and could mean the drug is being used regularly on patients in the next two or three years.
After seven successful Phase 2 trials in treating PTSD with MDMA — two in South Carolina, one in Colorado, one in Vancouver, one in Switzerland and one in Israel — MAPS showed their data to the FDA. The FDA saw the trials they had produced and agreed MAPS was ready to move to Phase 3. Which meant researchers didn’t need any other toxicology or abuse liability studies beforehand recruiting patients.
While the new designation doesn’t mean the drug is “FDA approved,” its breakthrough status will help fast track MDMA to approval. And that could be huge news for people living with PTSD, including survivors of sexual assault and U.S. military veterans. Dr. Mithoefer said the studies they’ve performed so far have worked with both people who first experienced PTSD after being the victims of a crime and people who first experienced PTSD after serving in the military.
“One thing I’ve learned in 40-plus years of practicing medicine is that different people respond to different treatment,” Dr. Mithoefer said. “I think it could be a very important addition to what we have to offer. We’ve had very big effects in people who have failed other treatments — both therapy and medication.”
The Phase 3 trials will be held in the U.S., Canada, and Israel, and they mark a historic development in the U.S. of psychedelic-assisted psychotherapy. It’s the first time a psychedelic drug has ever advanced to Phase 3 trials for possible prescription use in the United States.
The biggest difference between current PTSD treatment and MDMA-based treatment is that most of what doctors are using now — drugs like Zoloft — are aimed towards mitigating symptoms.
“No drug has ever been thought to cure PTSD,” Dr. Mithoefer said. “They don’t cure the problem and they have a lot of side effects when you are taking them every day.”
Dr. Mithoefer believes research in the field has proven that psychotherapy, which usually involves revisiting trauma, is a “definitive treatment” of PTSD. Yet, most of those psychotherapy programs have a very high drop-out rate. Typically, people can’t tolerate the treatment process.
“MDMA might help people stay in treatment and tolerate it better,” Dr. Mithoefer said. “It’s not just that people just get blissed out on MDMA and everything is fine — processing trauma is painful even if you’re taking MDMA. It’s just people say, ‘it’s still painful but I know I needed to do it.'”
In the trials, MDMA is usually a feature of a holistic approach that includes common treatment like talk therapy. Dr. Mithoefer emphasized that it’s not a “take home drug.” Patients typically only take it 2 or 3 times, during talk therapy or other forms of psychotherapy treatment.
Now that the FDA has given a signal it’s willing to explore the MDMA treatment, it appears the door will be left open for other psychedelic drugs to enter into the marketplace in the coming years. MAPS has already participated in studies using LSD and magic mushrooms to treat anxiety and help people quit smoking.
While none of these experts would advocate the recreational use of these drugs, it’s clear that under the watchful eye of medical professionals, there are some encouraging possibilities down the road.