The psychedelic drug MDMA could be approved for medical use to treat post-traumatic stress disorder following a federal regulatory meeting on Tuesday.
MDMA, also known as molly or ecstasy, has been clinically tested as a possible treatment for PTSD, a mental health condition closely linked to depression, anxiety and suicidal thoughts.
A panel of experts convened by the Food and Drug Administration met Tuesday to discuss whether the drug should be approved. The FDA usually accepts the panel’s recommendations, but a final decision likely won’t be issued until August.
MDMA has been outlawed since 1985, when the Drug Enforcement Administration classified it as a Schedule I drug, meaning it had high potential for abuse and no accepted medical use.
But various nonprofit groups, including the Multidisciplinary Association for Psychedelic Studies, have spent years testing MDMA and other psychedelics as possible treatments for conditions such as depression and anxiety. MAPS was the group that applied for FDA approval of MDMA, through its corporate spinoff Lykos Therapeutics.
MAPS technically applied for approval of MDMA-assisted therapy, as both clinical trials involved patients combining talk therapy with MDMA usage for treatment of PTSD. Both trials were conducted by MAPS, and their results showed MDMA-assisted therapy worked significantly better than therapy plus a placebo drug.
However, experts have questioned some aspects of the studies. Patients who were given the placebo or given MDMA were almost all able to tell which one they received. FDA clinical reviewers said that made it “nearly impossible” to maintain the so-called “blinded” objectivity needed for clinical trials.
Additionally, the reviewers were concerned that MDMA caused elevated heart rates in some participants, potentially triggering life-threatening heart problems.
Currently, antidepressants are the only FDA-approved treatment for PTSD. Officially, the FDA does not approve types of therapy, only drugs. However, it could approve MDMA with the condition that it be used in particular medical settings.
For example, it approved nasal spray similar to ketamine, Spravato, in 2019 that can only be used at certain health care facilities.
In 2023, Australia became the first country to approve the use of MDMA to treat PTSD, and psilocybin — the active ingredient in “magic” mushrooms — to treat certain forms of depression. Other nonprofits are conducting research on psilocybin in the U.S. and pushing for FDA approval.
With News Wire Services
