MDMA (ecstasy) is close to FDA-approved treatment for PTSD
The efforts of the Multidisciplinary Society for Psychedelic Research (MAPS) to legalize prescription ecstasy (Ecstasy) seem to have crossed a huge obstacle. Early this month: MDMA is expected to meet the testing requirements to become a legal prescription drug, specifically for the treatment of 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 that MDMA represents a potential breakthrough in the treatment of PTSD. This is huge news because the FDA has only approved a few antidepressants to treat PTSD, and about half of the patients cannot get relief from these drugs.
According to the analysis of an independent data monitoring company (DMC) coordinated by the FDA, the company reviewed the phase III data of MAPS after 60% of the subjects completed the study, and there is at least a 90% chance of undergoing the phase III test, which is statistically significant All participants received the results after treatment.The research results were published last week in Natural medicine, The famous trade magazine.
So, how did this research work? The scientists used a randomized, placebo-controlled study of 90 participants with severe PTSD. They found that MDMA can significantly reduce PTSD symptoms and dysfunction. Specifically, 67% of patients improved to the point that they no longer met the diagnostic criteria for PTSD, and one-third of patients had a complete remission. In addition, MDMA does not cause the possibility of abuse, suicide idealization or attempt, or adverse events such as QT prolongation. In the end, the research results show that MDMA adjuvant therapy is very effective in patients with severe PTSD, and MDMA treatment is safe.
The third phase of testing is critical to the legalization of prescription MDMA. At this stage, scientists evaluated the comparison of MDMA with existing PTSD drugs (such as Prozac, Zoloft, and Paxil). The third phase is also an important step from the first and second phases; the phase I trial only examines the safety of the drug, not the efficacy of the drug in humans, and the phase II trial investigates whether the drug is really combined with talk therapy Treat PTSD.
The result of the research is Rick Dobrin In particular, he has spent more than 30 years advocating the use of psychedelics to treat emotional trauma (sometimes, Doblin jokingly refers to MAPS as “the oldest startup in the world”). Founded by Doblin in 1986, MAPS is a non-profit organization headquartered in San Jose, California, dedicated to attracting funds and promoting the development of MDMA through the Food and Drug Administration (FDA) drug approval process. Since then, MAPS has guided MDMA to overcome various regulatory obstacles, and investors have invested a lot of money to study the efficacy of MDMA in the treatment of PTSD. Just last August, MAPS announced that it had raised US$30 million to complete the first phase of the MDMA Phase III study.
MAPS is preparing for the sprint, with the goal of obtaining FDA approval in 2022 and commercializing the drug in 2023. From now to then, the biggest challenge MAPS faces may be to raise hundreds of millions of dollars to complete the second phase III study, enter the field of drug production, and train therapists around the world for treatment.
We have been tracking MAPS and predicting the success of this treatment plan it’s been a while, We are very happy to see these results and follow MDMA to the direction of legalization. As we have already done, it can also pave the way for the approval of other psychedelic drugs in the FDA channel. Be covered On this blog for the past three years.