FDA Calls MDMA A Breakthrough For PTSD: Will Legal Treatments Follow?

The substance MDMA, best known as a party drug recreationally used by ravers, has been an unofficial (and illegal) treatment in some PTSD circles. Anecdotal reports of the drug's efficacy in helping free PTSD sufferers from their trauma have circulated for years, but conducting studies and offering official MDMA treatments in medical environments hasn't been possible. That all may be changing.

PTSD is a debilitating condition, and though some treatments have arisen that offer some degree of relief, no major treatment has made its way to the market. MDMA may be the solution. Some sufferers have, out of desperation, undergone MDMA treatment through underground methods, but the future of legal options is looking bright.

In a recent statement, the Multidisciplinary Association for Psychedelic Studies announced that the FDA has issued MDMA a 'Breakthrough Therapy Designation' for PTSD. By doing so, the FDA is agreeing with past findings that MDMA could be a better treatment option for PTSD than solutions presently available to sufferers.

In addition, the two entities have struck a Special Protocol Assessment Process deal that will result in two different Phase 3 trials using MDMA as part of psychotherapy for individuals described as having severe PTSD. The subjects for this trial will be selected starting next spring, though a 'lead-in training study' will start in coming weeks.

Between 200 and 300 patients with PTSD will be evaluated in the US, Canada, and Israel. The therapy will take place in three-day sessions across a 12-week treatment period, among other things. MAPS has already experienced astounding results in past studies. During its Phase 2 trials, 61-percent of participants no longer qualified as having PTSD after a mere 3 sessions of MDMA psychotherapy.

SOURCE: MAPS