The FDA says no—for now—to this psychedelic-assisted therapy for PTSD.
For years, psychedelic therapy has been gaining traction as an effective option for treating mental conditions such as anxiety disorder, depression, PTSD, even substance use disorder.
The standard clinical trial protocol for this research has been for participants to take the drug—often MDMA, LSD, or psilocybin (mushrooms)—while a therapist guides them during their hallucinogenic state.
Results have been promising, sometimes dramatically so, which is why the FDA’s recent decision not to approve MDMA-assisted therapy for PTSD surprised so many people in the mental health community.
The surprising but not so surprising FDA decision
The FDA’s “not for now” vote continues to receive a huge amount of publicity, mainly because the stakes are so high.
On the one hand, there are 13 million Americans—many but by no means all of them veterans—now living with PTSD, a highly debilitating and difficult condition to treat.
Lykos Therapeutics is the drug company that put forward the MDMA-assisted therapy application to the FDA. In Lykos’s most recent phase 3 clinical trial, 70 percent of participants no longer met the diagnosis of PTSD after just three sessions with MDMA plus talk therapy. Six months later, the participants still benefitted from the treatment.
Those are extremely promising outcomes.
On the other hand, the FDA had some compelling reasons for not approving Lyko’s application for MDMA-assisted therapy at this time.
Overall, the FDA found that the risks of treatment with such a powerful hallucinogen outweighed the data obtained from the clinical trials.
Specific FDA concerns included possible flaws in the study design, the high risk of abuse with the drug (which is why stringent guardrails are vital), plus possible side effects from MDMA use including cardiovascular problems.
Bottom line on the FDA’s decision: Their denial means that for now, MDMA remains a Schedule I drug under the Controlled Substances Act. Thus it “has no currently accepted medical use and a high potential for abuse,” as the DEA describes it.
An important caveat: In the FDA’s detailed denial letter to Lykos, they included what amounts to a roadmap for how Lykos or others may gain approval with this therapy.
Thoughts on psychedelic therapy from an addiction psychiatrist
For those in the space, this is a new and intriguing area of mental health treatment, and it clearly has potential. However, a slow, steady, cautious approach to mental health research must always be taken. There are too many possible risks and unintended consequences with MDMA to proceed otherwise.
Further thoughts:
- The accompanying therapy is key. Many researchers believe the real value of psychedelic-assisted therapy is not the drugs per se, but rather the guided therapy that occurs during the heightened state. In effect, the drugs clear a “receptivity” path by lowering the mind’s resistance, so therapy can be more effective.
- This isn’t fringe medicine. Opponents of psychedelic therapy sometimes paint psychedelic proponents as “fringe” researchers. In most cases, that’s simply not true. Regarding MDMA research alone, there are numerous, scientifically sound clinical trials at various stages of completion that are going on as we speak. Same goes for LSD and psilocybin research. Many of these scientific studies have been completed, and more are in the pipeline.
In terms of psychedelic-assisted therapy for anxiety disorder, to take just one example, a 2020 review of more than two dozen studies found that in two-thirds of them, participants reported significant reductions in their anxiety levels. There’s obviously something there we need to develop further.
- Beware the ketamine lesson. Ketamine serves as a cautionary tale when it comes to psychedelic therapy. “Friends” actor Matthew Perry’s accidental overdose death from ketamine last October only reinforces that need for caution.
An anesthetic pain killer with hallucinogenic effects in high doses, ketamine is now approved by the FDA as an effective treatment for depression. The key? To be safe and effective, ketamine therapy must be administered in a highly controlled, clinical setting by medical professionals. These are necessary guardrails the FDA stipulates for its use.
Unfortunately, “ketamine clinics” have sprung up, and many lack appropriate medical knowledge or experience with the drug. Ketamine is also readily available via rogue telemedicine companies that don’t always provide the necessary oversight with the therapy, and sometimes don’t have properly credentialed experts on staff.
The way ketamine is now abused is what is alarming about emerging psychedelic therapies. Those drugs (MDMA, LSD, psilocybin, and others) are powerful, and highly addictive. Without proper oversight guardrails, they can be badly abused. The FDA decision on MDMA reflects the caution we need to apply to these drug therapies.
Final thoughts on MDMA as a PTSD treatment option
To those living with PTSD and their loved ones, don’t be discouraged by the FDA ruling on MDMA-assisted therapy.
It was not a blanket denial that leaves no way forward for MDMA or other psychedelic therapies. Hope for these treatments remains, as does the urgency to find even better treatments for those with PTSD.
Meanwhile, please know there are very good options that exist now. Current, proven, trauma-focused therapies include cognitive behavioral therapy (CBT), prolonged exposure therapy (ET), eye movement desensitization and restructuring (EMDR), and others.
The two current FDA-approved medications that are helping people with PTSD include paroxetine (Paxil) and sertraline (Zoloft).
We need to make these PTSD therapies and medication more affordable and accessible to anyone who needs them. Starting now.
