WASHINGTON — Federal health authorities are questioning the safety and evidence behind the first attempt to use MDMA, the mind-altering club drug, as a treatment for PTSD. This is part of a decades-long effort by advocates to bring psychedelic drugs into the medical mainstream.
The Food and Drug Administration released its initial assessment of the drug on Friday, ahead of a meeting of outside advisers who could help decide whether MDMA — currently illegal under federal law — becomes the first drug of its kind to be approved by the U.S. medicine.
In their review, FDA scientists said patients given MDMA and talk therapy showed “rapid, clinically meaningful, durable improvements in their PTSD symptoms.” But they also called the study “challenging to interpret” and wondered how long the benefits could last. .
They said it's difficult to know how much of the improvement was due to MDMA versus simply undergoing intensive therapy, and also raised several safety concerns, including MDMA's heart risks and potential for abuse.
The outside experts will take a non-binding vote on the drug's overall benefits and risks at Tuesday's meeting. The FDA will make the final decision, likely in August.
Antidepressants are now the only FDA-approved medications for post-traumatic stress disorder, which is closely linked to depression, anxiety and suicidal ideation and is more common among women and veterans.
If approved, MDMA would be reclassified as a prescription drug and made available to specially certified physicians and therapists. Currently, the drug is in the same highly restrictive category as heroin and other substances that the federal government says are susceptible to abuse and have no medical use.
MDMA, also known as ecstasy or molly, is the first in a series of psychedelics expected to be reviewed by the FDA in the coming years. It's part of a resurgence of research into psychedelics' potential for hard-to-treat conditions like depression, addiction and anxiety. The main effect of MDMA is to induce feelings of intimacy, connection and euphoria.
Companies are studying MDMA, psilocybin, LSD and other mind-altering drugs for a host of mental health problems.
Until recently, psychedelic research was funded primarily by a handful of nonprofit advocacy groups, including the Multidisciplinary Association for Psychedelic Studies (MAPS). The company seeking approval for MDMA, Lykos Therapeutics, is essentially a spinoff of MAPS, which conducted all of the studies submitted for FDA review.
In two studies, patients were given MDMA as part of an intensive, four-month talk therapy course of more than a dozen sessions, only three of which involved the use of the drug. The drug is thought to help patients process their trauma and release disturbing thoughts and memories.
The approach was studied in nearly 195 adults with moderate to severe PTSD, who were randomly assigned to receive therapy with MDMA or a dummy pill. After treatment, patients who received MDMA had significantly lower PTSD scores and were more likely to achieve remission.
But FDA reviewers noted that the vast majority of patients correctly guessed whether they had been given MDMA or a fake pill, making it “nearly impossible” to maintain the so-called “blinded” objectivity considered essential for quality drug research. The agency also questioned how long the drug's benefits could last. The studies followed some patients for as long as two years, but reviewers noted that about a quarter of patients quickly dropped out of follow-up, limiting the usefulness of the results.
The most common side effects of MDMA were headache, nausea, muscle tension and loss of appetite. More serious problems included heart palpitations and increased blood pressure, which FDA reviewers said could cause life-threatening heart problems.
They also expressed concern about the potential for patients to abuse MDMA, which functions similarly to amphetamines and other stimulants.
Although MDMA would be a unique approval, American doctors and the FDA itself have already laid some of the groundwork for working with drugs that can cause intense, psychological experiences.
Hundreds of clinics in the US already offer ketamine – the powerful anesthetic sometimes used as a party drug – to treat a wide range of conditions, including depression, anxiety, chronic pain and PTSD. The FDA has only formally approved the drug for use during surgery, but its availability allows doctors to prescribe it “off-label” for a variety of mental and physical conditions.
In 2019, the FDA approved Johnson & Johnson's own form of the drug, Spravato, a nasal spray that treats severe depression. Like ketamine, the drug is offered in doctors' offices and clinics where patients typically spend several hours reclined in a chair.
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