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The US Food and Drug Administration (FDA) has determined that 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy, is a 'breakthrough therapy' in the treatment of post-traumatic stress disorder (PTSD).
Thanks to this designation, the drug could have a faster path to pharmaceutical approval.
The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the FDA's ruling last week, revealing that 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 trials will include 200 to 300 participants, and the first trial will begin to accept subjects in 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.
The trials will be held in the U.S., Canada, and Israel, and MAPS plans to open talks with the European Medicines Agency in the hopes of expanding testing to include Europe. For now, the focus is on securing the funding they require.
According to Science, the organisation is still in the process of raising money for the trials, and thus far, they've only managed to secure US$13 million, about half of their goal.
www.sciencealert.com
Thanks to this designation, the drug could have a faster path to pharmaceutical approval.
The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the FDA's ruling last week, revealing that 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 trials will include 200 to 300 participants, and the first trial will begin to accept subjects in 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.
The trials will be held in the U.S., Canada, and Israel, and MAPS plans to open talks with the European Medicines Agency in the hopes of expanding testing to include Europe. For now, the focus is on securing the funding they require.
According to Science, the organisation is still in the process of raising money for the trials, and thus far, they've only managed to secure US$13 million, about half of their goal.
Ecstasy Was Just Labelled a 'Breakthrough Therapy' For PTSD by The FDA
The US Food and Drug Administration (FDA) has determined that 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy, is a 'breakthrough therapy' in the treatment of post-traumatic stress disorder (PTSD).
www.sciencealert.com
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