The quest to legalize psychedelics for therapeutic purposes may soon take a big step forward.
A public benefit corporation called the Multidisciplinary Association for Psychedelic Studies submitted a drug application to the U.S. Food and Drug Administration this week that seeks approval to use MDMA capsules, in combination with therapy, to treat post-traumatic stress disorder, the company announced on Tuesday.
If approved, the application would pave the way for MDMA to be rescheduled from a Schedule I illegal drug under U.S. federal law and allow for it to be prescribed to PTSD patients for psychedelic-assisted therapy. The drug would be the first approved by the FDA for psychedelic-assisted therapy.
Known for years as a recreationally used, illegal party drug, MDMA has recently become the focus of a growing number of studies exploring the substance’s effectiveness in the treatment of mental health disorders, most notably PTSD and depression.
Though still illegal under federal law, MDMA was given a breakthrough therapy designation in 2017, a status which legally clears the way for the expedited exploration of a drug’s potential therapeutic value. Since then, studies and clinical trials showing MDMA’s effectiveness in treating PTSD and other mental health issues — including research conducted in the Philadelphia area — have piled up. In 2018, for example, a study from the University of California, Davis found that psychedelics like LSDA and MDMA may repair damaged neural circuitry well enough to treat symptoms of anxiety and depression.
MAPS, the public benefit corporation that submitted the drug application, has been involved in several clinical trials exploring the drug’s effectiveness for treating PTSD. One of those studies, published in the journal Nature earlier this year, found that MDMA-assisted therapy reduced PTSD symptoms in 86.5% of participants when compared to a placebo.
MDMA — also known as molly, ecstasy or methylenedioxymethamphetamine — is a synthetic drug that reduces feelings of fear and defensiveness while boosting feelings like trust and empathy, which clinicians say can enhance the effectiveness of psychotherapy. Delivered intermittently alongside psychotherapy, MDMA can help some patients acknowledge and work through past trauma and experiences.
Whether or not psychiatrists will start prescribing MDMA pills to help treat PTSD remains to be seen. The FDA is expected to respond to the application within 60 days.