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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.

19 of 266 comments (clear)

  1. Old news by Anonymous Coward · · Score: 5, Insightful

    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.

    1. Re: Old news by Anonymous Coward · · Score: 5, Informative

      In the 70s it was used for exactly this purpose and with great success. Then it got banned. "Breakthrough", lol, morons.

    2. Re: Old news by Opportunist · · Score: 4, Insightful

      You'll notice that every medicament that actually DOES work and where it's pretty much impossible to find something better gets outlawed, curiously around the same time the patent expires?

      But I'm sure it's mere coincidence that we find out what horrible, horrible side effects they might have just around that time.

      --
      We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
    3. Re: Old news by chihowa · · Score: 5, Informative

      The history of MDMA isn't one of patent abuse, but malfeasance by the DEA. The first MDMA synthesis patent was filed in 1912.

      MDMA was put on schedule I by the DEA against the guidance of the medical community, who sued to have it rescheduled. After a judge ruled that it had valid medical uses and should be rescheduled, the DEA unilaterally declared that it has no medical uses again and banned it.

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    4. Re: Old news by Rick+Schumann · · Score: 4, Insightful

      There are some who believe that the so-called 'pharma-medical-industrial complex' will suppress treatments and medications that actually cure, in favor of treatments and medications that merely control conditions and diseases, because there's no profit to be made when you don't have perpetual repeat business.

      Personally, I think that the entire pharmaceutical and medical industries should be mandated to be not-for-profit. With no motivation for the Few to get rich off the suffering of others, we'd see a big change in healthcare in this country.

  2. What about the Side effects? by Anonymous Coward · · Score: 4, Funny

    Side effects include getting into trance music, edm and attending raves. ðY

    1. Re:What about the Side effects? by Opportunist · · Score: 4, Insightful

      I'd be willing to take that risk. PTSD isn't fun, hell, if it would make me like dubstep or country, I'd still do it.

      --
      We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
  3. Please provide link to official FDA release by eggstasy · · Score: 4, Interesting

    We are scientists and engineers and should know better than post links to websites.
    Why should I trust MAPS instead of getting an actual FDA release? I couldn't confirm this myself on the FDA website.
    I don't know these people and they seem to have a vested interest in promoting this stuff, so it may be a bit overhyped.
    Let me know when Pfizer and Merck are looking into it ;)

    1. Re:Please provide link to official FDA release by arth1 · · Score: 5, Funny

      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.

  4. Re:Lies by Anonymous Coward · · Score: 5, Informative

    "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."

  5. Re:medicament by Opportunist · · Score: 4, Informative

    https://www.merriam-webster.co...

    It's not that often that a non-native speaker gets to teach a native speaker a new word, I guess.

    --
    We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
  6. Re:Also works great against depression by Wootery · · Score: 3, Insightful

    People are not supposed to be happy, at least not for very long. If people are happy they will not change anything to risk it going away.

    That's pretty braindead, even by the standards of conspiracy thinking.

    In the same paragraph, you say that happy people are less likely to want a revolution, but that the ruling elite don't want the masses to be happy. Am I missing something?

    Not to mention that the topic of discussion is clinical depression, not happiness.

    ACs never fail to disappoint.

  7. Re: medicament by Opportunist · · Score: 3

    It's easier than that. Medikament is German for medicine, and I'm a German native speaker. What happened here is me being out of caffeine and not translating a term properly.

    --
    We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
  8. Re:Also works great against depression by BarbaraHudson · · Score: 4, Informative

    The topic under discussion is PTSD, not clinical depression (btw - it's not called clinical depression any more - it's now known as major depressive disorder, to better distinguish it from run-of-the-mill depression that everyone gets once in a while and that's completely normal).

    PTSD is a form of anxiety disorder - a different kettle of fish. Sure, it's often accompanied by major depressive episodes, but it's important to understand that you're dealing with two different illnesses, and that curing PTSD won't necessarily cure MDD (especially since the brain is pretty plastic, and the more often you have an episode of major depression, the more likely you are to have another one).

    --
    "Transparent" is a shit show that trades on every stereotype going. A man in drag is NOT a transsexual.
  9. Re:Also works great against depression by BarbaraHudson · · Score: 5, Insightful

    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.
  10. Great News by VorpalRodent · · Score: 3, Funny

    I am ecstatic about this.

    --
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  11. Re:Also works great against depression by Opportunist · · Score: 3, Insightful

    Well, those pills rarely make you happy, but they motivate you. And the very last thing you want is a motivated and unhappy mob.

    --
    We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
  12. Helping the "right" people by Anonymous Coward · · Score: 5, Insightful

    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.

  13. MAPS by inicom · · Score: 5, Informative

    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.

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    -a.e.mossberg