MAPS Public Benefit Corporation has presented phase 3 data in the hopes of receiving the first major clearance for MDMA in the United States in the upcoming year. In point of fact, the achievement of success in the second late-stage research represents the culmination of over four decades worth of effort to demonstrate that psychedelics, when used to augment therapy, are effective in the treatment of post-traumatic stress disorder (PTSD).
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The researchers gave either MDMA or a placebo along with supportive counseling to around one hundred participants who suffered from moderate to severe PTSD. After 18 weeks, the scores on CAPS-5, a scale used to measure PTSD, had fallen by 23.7 in the MDMA side and by 14.8 in the control group, which caused the experiment to meet its primary aim.
In light of the fact that MDMA is considered to be a breakthrough medication, it may be eligible for expedited review. On the other hand, the MAPS PBC study may be subject to scrutiny, in particular, due to the fact that concealment may have been compromised due to the fact that the majority of participants were able to determine which side they were actually participating in.
In terms of the drug’s safety, five patients who were given MDMA had serious treatment-emergent adverse events, while only two of their peers who were given a placebo did so. When compared to the placebo group, those receiving MDMA were more likely to experience symptoms such as nausea, excessive perspiration, muscle tightness, and decreased appetite; however, the majority of these side effects were very temporary and ranged from mild to moderate in intensity.
MAPS PBC plans to make use of the findings from the two phase 3 studies in order to submit an application to the FDA for approval before the conclusion of the year. If the group were to achieve its goal, they would be well on their way to receiving permission for the next year.
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