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FDA Designates MDMA As 'Breakthrough Therapy' For PTSD (futurism.com)

Posted by BeauHD on from the progressive-treatments dept.

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.

44 of 266 comments (clear)

  1. Also works great against depression by Opportunist · · Score: 2

    As nonclinical studies have shown...

    Then again, who'd want people to not be depressed and compensate by buying shit?

    --
    We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
    1. 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.

    2. Re:Also works great against depression by arth1 · · Score: 2

      Very insightful observation. 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. A ruling elite wants people to be unhappy and afraid.

      I think it's the other way around. A complacent population is easier to handle. Never has there been a more drugged people than today's Americans - 70% take at least one prescription drug, plus a huge amount of over-the-counter and illicit drugs. As long as people function well enough to earn their wages, pay their taxes, and vote for those who speak in short enough sentences to understand, it's all good from a government point of view. Whether you shuffle to and from work as a zombie, and sit plastered in front of the TV or redtube all night doesn't matter, as long as you don't rock the boat.

    3. 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.
    4. 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.
    5. 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.
    6. Re:Also works great against depression by PolygamousRanchKid+ · · Score: 2

      Never has there been a more drugged people than today's Americans - 70% take at least one prescription drug, plus a huge amount of over-the-counter and illicit drugs.

      "If you feel you are not properly sedated, call 348-844 immediately. Failure to do so may result in prosecution for criminal drug evasion."

      Whether you shuffle to and from work as a zombie, and sit plastered in front of the TV or redtube all night doesn't matter, as long as you don't rock the boat.

      Male voice (medicine cabinet): "What's wrong?"
      Man: "I need something stronger."
      Male voice (medicine cabinet): "Take four red capsules. In 10 minutes, take two more. Help is on the way."

      --
      Schroedinger's Brexit: The UK is both in and out of the EU at the same time!
    7. Re:Also works great against depression by arth1 · · Score: 2

      How many of that 70% are taking a non-psychoactive drug--for high blood pressure, high cholesterol, or diabetes? Hardly an argument that we're a nation of drugged zombies.

      The most common drug for hyptertension (high blood pressure) is lisinopril, which has a major common side effect of depression.
      The most common drugs for high cholesterol are statins, which have a major common side effect of severe muscle pain, often leading to secondary prescriptions of opiates.
      The most common drug for diabetes type II is metformin, which has a major common side effect of sleepiness.

    8. Re:Also works great against depression by Rick+Schumann · · Score: 2

      You almost have it, but not quite.
      The so-called 'ruling elite' want people to be in a constant state of terror, because that effectively turns off their higher reasoning abilities, and in their perpetual panic, they look for someone, anyone, who appears to be able to 'save them'.

  2. 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 605dave · · Score: 2

      My therapist worked on the trials back in the 70s, and said the results were amazing when treating PTSD and anxiety. I have long hoped that this could happen, but am surprised it actually has.

      --
      Be kind, for everyone you meet is fighting a difficult battle. - Plato
    4. 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.

      --
      If you want a vision of the future, imagine a youtube comments section scrolling - forever.
    5. 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".

    6. Re:Old news by kilfarsnar · · Score: 2

      Perhaps someone on the Left can answer this for me, but why is it that the Left objects so strongly to the exploitation of the weak by corporations, but considers exploitation by drug dealers to be a positive social good?

      As a member of the Left, I'd like to know where you got the notion that anyone on the Left thinks that way. Please point out where a person has said that exploitation by drug dealers is a social good, or admit this is a strawman.

      People in general think the war on drugs is bad because the supposed cure is worse that the disease. I would much rather be addicted to heroin than serving time on a 20 year prison sentence. I can kick the smack, but I can never get rid of a felony record.

      Perhaps someone on the Right can explain to me why putting someone in jail for years, and ruining their employment prospects when they get out is preferable to them having a drug habit.

      --
      "What the American public doesn't know is what makes them the American public." -Ray Zalinsky (Tommy Boy)
    7. Re:Old news by kilfarsnar · · Score: 2

      Right, because drugs themselves haven't condemned MILLIONS of people to decades of suffering either?

      Look, I understand your point: the 'war on drugs' is stupid. I agree. But to assert that the absence of MDMA as a theraputic resources is even within what, four? five? more? orders of magnitude the overall hurtful impact of class 1 substances generally is just silly.

      Class 1 substances like marijuana, LSD and Peyote? These drugs do not cause suffering.

      --
      "What the American public doesn't know is what makes them the American public." -Ray Zalinsky (Tommy Boy)
    8. 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.

  3. 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.
  4. Re:It kills active brain clusters. by bluegutang · · Score: 2

    Only for long term users. This therapy is short term.

  5. 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.

  6. 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."

  7. Re: medicament by Anonymous Coward · · Score: 2, Funny

    A medical predicament, duh!

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

    "we did a double blind test to see if it worked" seems like science to me.

    What is unscientific about proposing a hypothesis and testing it?

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

    They would have a hypothesis, observation and conclusion which may simply be "more research needed" that IS science. Science isn't the answer, it's the process.

  10. Re:It kills active brain clusters. by Opportunist · · Score: 2

    What other long time study of MDMA do you know about? MDMA is in no country on this planet a substance that you can use in human studies, so where do you think these results come from?

    --
    We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
  11. 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.
  12. fda site by umghhh · · Score: 2

    says no such thing. In WIKI it says that sideeffects need further study. Then again - memory impairment means you forget about stuff that made you sick right? If that could work with mother of my kids I would buy this shit immediately.

  13. 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.

  14. 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.
  15. Re:medicament by arth1 · · Score: 2

    Wtf is a "medicament"?

    A good word that has fallen out of common use in the US, but is still part of English, and should be known by everyone. Note that your spell checker accepted it when you typed it in - that should have been a clue to look it up before jerk posting.

    A medicament is a healing substance, curative or remedy. It's a noun that describes a larger group partially overlapping medicine and medication. Vaseline on skin is a medicament. So are antibiotics. But a pure symptom suppressor is not necessarily a medicament.

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

    Cinnamon Toast Crunch.

  17. Re:don't know how "disease" or drug works,try it! by Gilgaron · · Score: 2

    It can still be science if part of the process is black boxed. If anything, science shines a harder light on what the boundaries of the black box are.

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

    I am ecstatic about this.

    --
    Take it to the limit, everybody to the limit, come on, everybody fhqwhgads.
  19. Re: Lies by GuB-42 · · Score: 2

    Molly usually means MDMA in crystal/powder form, ecstasy in pill form.
    Pills contain inactive binders but besides this, it says nothing about purity. Molly crystals can also be meth, alum, anything. There is no shortage of vaguely crystalline translucent substances. If you look at esctasydata.org you'll see that the most pills sold as ecstasy contain only MDMA as an active substance and that not all "molly" is pure.
    As for safety, crystal is easier to dose visually but pills are more a bit more traceable. In the end, one is not better than the other.

  20. Science (magazine) says: by OneAhead · · Score: 2

    One of the main targets in the war on drugs could well become a drug to treat the scars of war.

    I bet the journalist who came up with that sentence felt good about himself :)

  21. 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.

  22. 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.

    1. Re:Helping the "right" people by kilfarsnar · · Score: 2

      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.

      I don't disagree. But Americans are a very war-like people, so appealing to their militarism often works. It's how we got the interstate highway system, after all.

      --
      "What the American public doesn't know is what makes them the American public." -Ray Zalinsky (Tommy Boy)
  23. 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.

    --
    -a.e.mossberg
  24. Re: Lies by koreanbabykilla · · Score: 2

    MDMA:
    https://erowid.org/library/boo...
    MDA:
    https://erowid.org/library/boo...

  25. Re:Prevention is the best medicine by Actually,+I+do+RTFA · · Score: 2

    While war may be the most famous cause, PTSD has a lot of non-war causes as well.

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