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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.

14 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 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.
    2. Re:Old news by Anonymous Coward · · Score: 2, 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?

      This is what happens when you have governments making policy which isn't evidence/science based, so they can pander to idiots who think their holy book has told us everything we need to know about the universe and wish to impose their idiocy on the rest of the world.

      Whiny Christians, Islamc fundamentalists, Orthodox Jews, backwards assed Hindu mystics .. at the end of the day, it's time the rest of us stopped being held captive to the fixed and crazy beliefs of people who refuse to use evidence and instead wish to impose their beliefs on everyone else.

      In America, it's the Christian Right. But it's all the same fucking shit.

      You can't make scientific policy which panders to the drooling morons who say "all drugs are bad no matter what, especially if people might also use them for fun".

    3. 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. 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. Re: medicament by Anonymous Coward · · Score: 0, Insightful

    The problem is that it is an arcane form that no native speaker would use because it would identify one as either a) a non-native speaker who still occasionally uses an awkward turn of phrase or b) a pedantic asshole for whom showing off a large vocabulary is more important than clarity or intelligibility.

  4. Re: Lies by Anonymous Coward · · Score: 2, Insightful

    Show me another placebo with 60+% efficacy in a double blind trial and get back to me.

  5. 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.

  6. Re: Lies by Anonymous Coward · · Score: 2, Insightful

    Cinnamon Toast Crunch.

  7. 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.
  8. Re:don't know how "disease" or drug works,try it! by Anonymous Coward · · Score: 2, Insightful

    this is not science; we have no firm idea how "disease" or drug works, but let us try it anyway to see whether it will work.

    You're an idiot.

    Science requires a testable hypothesis ... which in this case could be "we have people who are not happy, we have a compound which induces happy, what happens if we combine the two".

    MDMA, LSD, and in fact cocaine as famously applied by Freud, and quite possibly marijuana; these are things which have been identified as possibly impacting some aspects of mental health in a positive way.

    But when you can't perform any research because some idiot politician has summarily decided it is illegal and without redeeming value, that isn't science.

    We lack a firm understanding of the mechanics of many diseases, but that doesn't stop us from looking for possible correlations in how to treat it.

    You are stupidly saying "you have diseases, and you have cures, tried and tested to work in most cases", but how the fuck do you think we found the goddamned cures you moron? Do you really think it was from a complete and total understanding of the disease from the start?

    Science is the willingness to try things, keep track of your results, and measure the effects.

    Saying you can't conduct science because the decision has already been made with out .. that's not fucking science, that's religion.

  9. 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.
  10. 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.

  11. Prevention is the best medicine by edi_guy · · Score: 1, Insightful

    Or how about not sending 10,000's of Americans into war in the first place?
    Actually political bi-partisanship only seems to manifest itself when the US decides to bomb, invade, or otherwise destabilize distant lands at the expense of the U.S. soldiers thrust into the cauldron.