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FDA Designates MDMA As 'Breakthrough Therapy' For PTSD (futurism.com)
In what could lead to a faster path to pharmaceutical approval, the U.S. Food and Drug Administration (FDA) has designated methylenedioxymethamphetamine (MDMA) as a "breakthrough therapy" in the treatment of post-traumatic stress disorder (PTSD). Futurism reports: 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. 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 organization is still in the process of raising money for the trials, and thus far, they've only managed to secure $13 million, about half of their goal.
Previous MAPS trials exploring how well MDMA could treat PTSD have yielded favorable results, contributing to the FDA's aforementioned decision. In the association's Phase 2 trails, 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, according to the MAPS press release.
Previous MAPS trials exploring how well MDMA could treat PTSD have yielded favorable results, contributing to the FDA's aforementioned decision. In the association's Phase 2 trails, 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, according to the MAPS press release.
When did Shulgin first synthesise this? Wasn't there a huge push at the time to use it for therapy, before the government scheduled and stomped on it with a 'no possible medical use' bullshit?
Thanks, war on drugs pricks, for condemning tens of thousands of people to decades of suffering.
"In the association’s Phase 2 trails, 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, according to the MAPS press release."
Merck held the original patent for MDMA - marketed as a weight loss drug for ladies with interesting side effects.
But the studies were cut short when they ran out of ladies with interesting side effects.
Worse, it's not the FDA that is waging a war on drugs in the first place. The "war on drugs" is a political construct with no scientific evidence backing it. If the FDA were to be allowed to do studies to prove or disprove its effectiveness, the "war on drugs" would end pretty quickly. Ditto with the epidemiology of lack of gun control causing increased deaths..
"Transparent" is a shit show that trades on every stereotype going. A man in drag is NOT a transsexual.
Very clever how this current effort to legalize MDMA was designed. Focusing on PTSD as the indication, and how it could help all those brave patriotic veterans.
Instead of dirty depressed hippies and single mom assault victims, who are leeches on society totally undeserving of pharmaceutical treatment.
This political smokescreen is the only reason the study managed to survive the tender minstrations of the DEA.
Anyone not familiar with MAPS: Multidisciplinary Association for Psychedelic Studies should check them out and support them if possible. They have been at the forefront of supporting research and helping researchers navigate the complex legal/political terrain for decades. Highly recommended group.
-a.e.mossberg