The United States FDA gives ecstasy "breakthrough" status in PTSD treatment trials
The drug also enters Phase II testing
The Food and Drug Administration has just labeled MDMA as having "breakthrough" status and has been approved for Phase II trials of PTSD treatment.
The investigative tests, which will cost approximately $25 million, will be funded by the Multidisciplinary Association for Psychedelic Studies and potentially wrap as soon as 2021.
Assessments of ecstasy to treat Post Traumatic Stress Disorder started in the US in 2011 and have since shown positive results.
The primary symptoms of those who suffer from PTSD include flashbacks and debilitating mental and emotional distress following traumatic events, triggered by varying elements.
In previous trials, subjects were given three different dosages of MDMA, with the full dose capping at an initial 125mg followed by an optional supplemental dose of 62.5mg, one and a half to two and a half hours later.
The MDMA treatment demonstrated that out of 107 subjects, within two months 61 per cent no longer showed PTSD symptoms. After a full year, 68 per cent did not.
If all goes well, MDMA therapy will be the first time psychedelic-assisted psychotherapy will be evaluated in Phase III trials for possible prescription use.
[Via: Washington Post / Multidisciplinary Association For Psychedelic Studies]
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