The US Food and Drug Administration has just officially determined that 3, 4-methylenedioxymethamphetamine (MDMA)—also known as ecstasy—is a ‘breakthrough therapy’ in the treatment of post-traumatic stress disorder (PTSD). The designation could send the drug on the fast-path to pharmaceutical approval.
At the end of August, the Multidisciplinary Association for Psychedelic Studies announced the FDA’s ruling, noting they can now move forward on two of their upcoming ‘Phase 3’ trials. The goal of these trials is to determine how effectively the drug can be used to treat those suffering from PTSD.
The MAPS’ phase 2 trials, 107 people who had PTSD for an average of 17.8 years were treated using MDMA-assisted psychotherapy. After two months, 61 percent of the participants no longer suffered from PTSD. After a year, that number increased to 68 percent. Those are huge numbers considering nearly 8 million adults experience PTSD per year.
The trials will be held in the U.S., Canada, and Israel and will observe 200 to 300 participants as early as 2018.
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said Rick Doblin, Founder and Executive Director of MAPS.
For now, the focus is on securing the funding they require. The organization is still raising money for the trials and have only reached about half of their goal.
MAPS has been conducting MDMA trials since 1986, with hopes of proving the drug’s therapeutic value. The drug gained traction as a potential treatment for PTSD more than five years ago, but the drug’s stigma as a street drug has been a roadblock.
“This is not a big scientific step,” David Nutt, a neuropsychopharmacologist at Imperial College London, explained to Science. “It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance.”
If MDMA is proven to be an effective and safe treatment, it could help millions of people live normal, healthy lives.
Source: Science Alert