A specialized company studying the benefits of psychoactive drugs submitted a request to the Food and Drug Administration this week for approval to use MDMA – also known as ecstasy or molly – in conjunction with modern therapy to treat post-traumatic stress disorder. If approved, this combined therapy will be the first of its kind – a psychedelic-assisted therapy. Approval will also require the Drug Enforcement Administration to reschedule MDMA, which currently belongs to the most restricted category under the DEA, Schedule I, defined as drugs “with no currently accepted medical use and a high potential for abuse.” This category also includes LSD, heroin, and marijuana.
Beneficiary Company of the Request
The beneficiary company of the FDA request was established by MAPS, the Multidisciplinary Association for Psychedelic Studies, which has supported this kind of work since 1986. The application is based on positive data from two Phase III randomized, double-blind, placebo-controlled trials, funded and organized by MAPS and MAPS PBC.
Clinical Studies
The first study, published in the journal Nature Medicine in 2021, involved 90 participants suffering from moderate post-traumatic stress disorder. It found that MDMA-assisted psychotherapy (also known as psychotherapeutic treatment) significantly improves outcomes on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) compared to participants who received psychotherapy with a placebo. The second study, published in September in Nature Medicine, confirmed the results among 104 participants suffering from moderate to severe post-traumatic stress disorder (73 percent of whom suffer from severe PTSD).
Mechanism of Action of MDMA
MDMA – 3,4-methylenedioxymethamphetamine – affects neurotransmitters in the brain, specifically increasing the activity of serotonin, dopamine, and norepinephrine. This leads to experiences of hallucinations and perceptions, enhanced sensory perception, and increased social effects, but it can also cause confusion, depression, and delusional disorders. Its use in psychotherapy has been explored for decades.
Challenges of MDMA-Assisted Psychotherapy
MDMA-assisted psychotherapy has faced criticism due to anticipated accessibility challenges. The therapy described in the trials involves long and costly therapy sessions with highly trained therapists. The Washington Post reported an estimated cost between $13,000 and $15,000 for a round of therapy, and it remains unclear whether it will be covered by health insurance if approved by the FDA. Allen Frances, a former professor of psychiatry at Duke University, told the Post: “Most people in the world will not be able to afford these clinics.”
Potential Future of MDMA-Assisted Psychotherapy
After submitting the new drug application, the FDA has 60 days to determine whether it will be accepted for review and whether it will be a priority review or a standard review (six or ten months, respectively), as indicated by MAPS PBC. MAPS is seeking a priority review. In 2017, the FDA granted MDMA “Breakthrough Therapy” designation, intended to help expedite the development and review of drugs for serious conditions when the evidence suggests that they may significantly improve upon existing treatments.
Previous Approval of Psychoactive Drugs
The only psychoactive drug that has received FDA approval so far is esketamine, a derivative of ketamine, which was approved in 2019 for the treatment of treatment-resistant depression.
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