Legalizing MDMA for PTSD Treatment: How Close Are We?
By Andrew Smith
The efforts of the Multidisciplinary Association for Psychedelic Studies (MAPS) to legalize prescription MDMA (Ecstasy) appear to have cleared a gigantic hurdle earlier this month: MDMA is on track to meet the testing requirements for a legalized prescription drug specifically designed for Treatment by prescription drug intended is symptoms of post traumatic stress disorder (PTSD).
After analyzing the preliminary results of the latest Phase III study on the effects of MDMA, scientists believe MDMA represents a potential breakthrough in PTSD treatment. This is big news because the FDA has approved few antidepressants for the treatment of PTSD, and about half of patients don’t get relief from these drugs.
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According to an analysis by an FDA-coordinated independent data monitoring company (DMC) that reviewed MAPS ‘Phase III data after the study was completed by 60% of subjects, there is a 90% or more chance of having the Phase III testing Results are statistically significant as soon as all participants have been treated. The results of the study were published last week in Nature Medicine, a prestigious journal.
How did the study work? The researchers used a randomized, placebo-controlled study of 90 participants who had severe PTSD. They found that MDMA significantly reduced PTSD symptoms and dysfunction. In particular, 67% of patients improved enough to no longer meet the diagnostic criteria for PTSD, and a third experienced complete remission. In addition, MDMA did not induce any adverse events with potential for abuse, suicide idealization or attempts, or QT prolongation. Ultimately, the results of the study show that MDMA-assisted therapy is highly effective in patients with severe PTSD and that MDMA treatment is safe.
Phase III testing is critical to legalizing prescription MDMA. At this stage, scientists evaluate how MDMA compares to existing drugs used to treat PTSD such as Prozac, Zoloft, and Paxil. Phase III is also a significant step up from Phase I and Phase II; Phase I studies look at the safety of the drug but not the effectiveness of the drug in humans, and phase II studies look at whether the drug actually treats PTSD in conjunction with talk therapy.
RELATED: MDMA Close to FDA Approval
The study results are a huge win, especially for Rick Doblin, who has been advocating the use of psychedelic drugs to treat emotional trauma for more than 30 years (Doblin sometimes jokingly refers to MAPS as “the world’s oldest start-up”). Founded in 1986 by Doblin, MAPS is a San Jose, Calif. Based nonprofit committed to promoting funding through the Food and Drug Administration (FDA) drug approval process and seeing MDMA. Since then, MAPS has pushed MDMA through various regulatory obstacles and investors have contributed large amounts of money to study MDMA’s effectiveness in treating PTSD. Just last August, MAPS announced it had raised $ 30 million to complete this first Phase III MDMA study.
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MAPS is preparing for a sprint to the finish line, aiming for FDA approval in 2022 and drug marketing in 2023. By then, the biggest challenge for MAPS will likely be to raise a few hundred million more to complete a second Phase III study, get into drug manufacturing and train therapists around the world to deliver treatments.
RELATED: Legal MDMA-Assisted Therapy For PTSD Expected By 2022
We have been following MAPS for some time and predict the success of this treatment regimen. We were thrilled to see these results and to follow MDMA’s progress toward legalization. It could also pave the way for other psychedelics to be approved on the FDA channel, as we’ve been reporting on this blog for the past three years.
This article originally appeared on the Canna Law Blog and was republished with permission.