MDMA trials make headway with FDA approval
MDMA trials have gotten to Phase 3 regarding FDA approval.
The war on drugs makes a U-turn as MDMA could be used to treat those suffering from war-afflicted as well as general PTSD.
Last week MAPS shared the exciting news that the FDA has granted Breakthrough Therapy Designation to MDMA to aid PTSD.
After many years of promising trials the FDA “has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD,” MAPS said in a press conference.
MAPS has reached an agreement with the agency under the Special Protocol Assessment Process, in which they will design two Phase 3 trials for MDMA-assisted psychotherapy for patients suffering from severe PTSD in the near future.
It has been a major priority for the MAPS team to work closely with the FDA and get the trials to this exciting phase, one step closer to getting that all-important FDA approval.
FDA and MDMA
The results from the Phase 2 trials completed by MAPA showed that 61% of the 107 participants no longer qualified for PTSD a mere 2 months after undergoing 3 sessions of MDMA-assisted psychotherapy.
After a year, that number grew to 68%, an amazing feat considering some of those participants suffered from chronic, treatment-resistant PTSD for an average of 17.8 years.
In Phase 3, the randomized, placebo-controlled trials will assess the safety and efficiency in a group of 200 to 300 participants as they undergo MDMA-assisted psychotherapy.
The trials could start in the next year and wrap up by 2021 if MAPS is able to source an estimated $25 million of funding.
Neuropsychopharmacologist David Nutt told Science, “This is not a big scientific step … It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance.”
It’s high time that the euphoria-inducing feel-good drug, MDMA, is put to good use in alleviating the pain of PTSD.
May these next MDMA trials bring forth a positive verdict!