A specialized company studying the benefits of psychedelics has 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.
The Effects of MDMA on the Brain
MDMA – 3,4-methylenedioxymethamphetamine – affects neurotransmitters in the brain, increasing the activity of serotonin, dopamine, and norepinephrine. This leads to experiences for those taking the drug such as hallucinations, visual perceptions, enhanced sensory perception, and a love for social interaction, but it can also cause confusion, depression, and psychotic disturbance. Its use in psychotherapy has been explored for decades.
Clinical Studies
The request is based on positive data from two phase three clinical studies, funded and organized by MAPS and MAPS PBC. In the first study published in Nature Medicine in 2021, 90 participants suffering from moderate post-traumatic stress disorder were involved. The MDMA-assisted therapy was found to significantly improve CAPS-5 scale outcomes for post-traumatic stress disorder compared to participants who received placebo-assisted therapy. In the second study, published in September in Nature Medicine, the results were confirmed among 104 participants suffering from moderate to severe post-traumatic stress disorder (73 percent of whom had severe post-traumatic stress disorder).
Treatment Details
In both trials, participants took doses ranging from 80 to 180 mg of MDMA or placebo at the beginning of three eight-hour sessions, spaced approximately a month apart. Between those experimental sessions, participants also had three 90-minute sessions to process the experimental experience.
Submission for Approval
In a statement this week, the CEO of MAPS PBC, Amy Emerson, celebrated the new drug application to the FDA. She said, “Our submission is the result of over 30 years of clinical research, advocacy, collaboration, and dedication to providing a potential new option for adults suffering from post-traumatic stress disorder, who are a group of patients who have not seen much innovation for decades.”
MAPS founder and president Rick Doblin also celebrated the application this week, stating: “When MAPS started in 1986, the FDA was still obstructing all research related to psychedelics. … By breaking this barrier, we opened the door for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine, and others. The new approach to psychedelic-assisted therapy research has led to profound shifts in our understanding of how to treat these devastating mental health conditions.”
Criticisms of the Treatment
So far, MDMA-assisted therapy has faced criticism over expected access difficulties. The treatment outlined in the MDMA clinical trials involves long and costly therapy sessions with highly trained therapists. The Washington Post estimated the cost between $13,000 to $15,000 for a round of treatment, and it remains unclear if it will be covered by health insurance if approved by the FDA. Alan Frances, a professor of psychiatry at Duke University, told the Post: “Most people in the world will not be able to afford these clinics.”
Now that the new drug application has been submitted, the FDA has 60 days to determine whether it will be accepted for review and whether it will be a priority review or standard review (six months or ten months, respectively), MAPS PBS stated. MAPS is seeking priority review. In 2017, the FDA granted MDMA “breakthrough therapy” designation, designed to help expedite the development and review of drugs for serious conditions when the evidence indicates it may provide substantial improvement over existing therapies.
The drug
The only psychedelic that has received approval from the FDA so far is esketamine, a derivative of ketamine, which was approved in 2019 for the treatment of treatment-resistant depression.
Source: https://arstechnica.com/science/2023/12/mdma-aka-ecstasy-submitted-to-fda-as-part-of-ptsd-therapy/
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