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posted by cmn32480 on Wednesday August 30 2017, @01:38PM   Printer-friendly
from the and-the-side-effects-are.... dept.

The U.S. Food and Drug Administration has given its approval for Phase 3 trials to treat participants with PTSD using MDMA ("ecstacy"):

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.

MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct. By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.

The first Phase 3 trial (MAPP1), "A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder," will begin enrolling subjects in Spring 2018, after the completion of an open-label lead-in training study at Phase 3 sites starting this fall.

[...] The Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

In MAPS' completed Phase 2 trials with 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.

Also at ScienceAlert, the Washington Post, and Science Magazine:

Since 2012, FDA has designated close to 200 drugs as breakthrough therapies, a status that indicates there's preliminary evidence that an intervention offers a substantial improvement over other options for a serious health condition. The agency aims to help develop and review these treatments faster than other candidate drugs.


Original Submission

Related Stories

Ketamine Shows Promise as a Fast-Acting Treatment for Depression 14 comments

Ketamine could become an approved treatment for depression in the UK soon:

Ketamine has 'fast-acting benefits' for depression

Ketamine has "shown promise" in the rapid treatment of major depression and suicidal thoughts, a US study says. Ketamine has a reputation as a party drug but is licensed as an anaesthetic. The study found use of the drug via a nasal spray led to "significant" improvements in depressive symptoms in the first 24 hours. The Royal College of Psychiatrists said it was a "significant" study that brought the drug "a step closer to being prescribed on the NHS".

The report by researchers from Janssen Research and Development, a Johnson and Johnson company, and Yale School of Medicine, is the first study into ketamine as a treatment for depression that has been done by a drug company.

[...] The study found those using esketamine had a much greater improvement in depression symptoms at all points over the first four weeks of treatment. However, at 25 days the effects had levelled out. The study's authors suggest it could offer an effective rapid treatment for people severely depressed and at imminent risk of suicide and could help in the initial stages of treatment, as most anti-depressants take four to six weeks to become fully effective.

Also at Medical Daily.

Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study (DOI: 10.1176/appi.ajp.2018.17060720) (DX)

Can a Framework Be Established for the Safe Use of Ketamine? (DOI: 10.1176/appi.ajp.2018.18030290) (DX)

Related: FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Study Suggests Psilocybin "Resets" the Brains of Depressed People
Ketamine Reduces Suicidal Thoughts in Depressed Patients
Studies Identify How Ketamine Can Reverse Symptoms of Depression
Over Years, Depression Changes the Brain, new Study Shows


Original Submission

FDA to More Strictly Regulate Homeopathic Drugs 47 comments

The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):

To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.

"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."

FDA draft guidance (8 pages).

Also at Ars Technica and STAT News.

Related: Probiotics Come with Bold Health Claims, but the Science is Shaky
What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Supplement Maker on FDA Blacklist After Deadly Bacteria Found in Water System
FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Homeopathic "Healing Bracelet" Poisons Baby With High Levels of Lead
FDA: Love is Not an Ingredient
FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
Biohackers Disregard FDA Warning on DIY Gene Therapy


Original Submission

Studies Identify How Ketamine Can Reverse Symptoms of Depression 26 comments

New studies zero in on roots of depression and why ketamine reverses it

[There's] been significant progress in unravelling the confusion over ketamine, with researchers identifying a ketamine derivative that tackles depression with far fewer side effects. And this week, a team of researchers at China's Zhejiang University announced that they've figured out where in the brain ketamine acts when it blocks depression, a finding that gives us significant insights into the biology of the disorder.

The new studies rely on the work of a number of other labs, which have identified a specific structure deep in the brain that's associated with depression. Called the lateral habenula, it's been associated with a variety of activities, the most relevant of which seems to be the processing of unpleasant outcomes and punishment. Electrodes implanted there have been used to relieve depression in at least one instance.

To test whether this might be the site of ketamine's activity, one team of researchers infused the drug directly into the lateral habenula of rats with depression-like symptoms; it blocked them. So did a separate chemical that inhibits the same proteins that ketamine acts on. Tracking the activity in the area, the researchers were able to show that there are bursts of activity in rats with symptoms of depression that are absent in healthy rats. The drugs that blocked depression suppressed these bursts.

Ketamine blocks bursting in the lateral habenula to rapidly relieve depression (DOI: 10.1038/nature25509) (DX)

Astroglial Kir4.1 in the lateral habenula drives neuronal bursts in depression (DOI: 10.1038/nature25752) (DX)

Related: FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Study Suggests Psilocybin "Resets" the Brains of Depressed People
Ketamine Reduces Suicidal Thoughts in Depressed Patients


Original Submission

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  • (Score: 1, Interesting) by Anonymous Coward on Wednesday August 30 2017, @01:44PM (14 children)

    by Anonymous Coward on Wednesday August 30 2017, @01:44PM (#561493)

    What will they re-invent next? Maybe therapy combined with LSD as successfully trialed (by Tim Leary and others) in the early 1960s?

    • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @01:48PM (1 child)

      by Anonymous Coward on Wednesday August 30 2017, @01:48PM (#561494)

      nah, it'll go mainstream and be used to make more people completely delusional. see the 'news' on doping populations with oxy and watch 'brave new world'; things you liked used against you. oh yawn.

      • (Score: 2, Insightful) by Anonymous Coward on Wednesday August 30 2017, @02:22PM

        by Anonymous Coward on Wednesday August 30 2017, @02:22PM (#561509)

        It's not mainstream enough until kids can buy it out of a vending machine just like caffeine.

    • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @01:55PM (4 children)

      by Anonymous Coward on Wednesday August 30 2017, @01:55PM (#561499)

      Too lazy to cite, but I vaguely recall some research somewhere indicating that symptoms of depression appeared immediately following administration of LSD. Given how much it messes with serotonin, it sounded reasonable. That will likely put a damper on any future research on LSD as a kind of therapy, at least without some kind of pairing with SSRIs of some sort after the "session".

      • (Score: 3, Informative) by Scottingham on Wednesday August 30 2017, @02:42PM

        by Scottingham (5593) on Wednesday August 30 2017, @02:42PM (#561518)

        That's odd, I've heard the exact opposite with LSD. Though I too am too lazy to cite.

        Are you perhaps confusing it with the after-effects of MDMA? That is definitely associated, especially in an uncontrolled setting with an unknown dosage, symptoms of depression.

      • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @03:25PM (1 child)

        by Anonymous Coward on Wednesday August 30 2017, @03:25PM (#561532)

        Too lazy to cite, but I vaguely felt the symptoms of thinking you're a dumbass set in after reading your comment.

        • (Score: 2) by edIII on Wednesday August 30 2017, @09:26PM

          by edIII (791) Subscriber Badge on Wednesday August 30 2017, @09:26PM (#561739)

          Oh no. I think it's contagious.

      • (Score: 3, Interesting) by takyon on Wednesday August 30 2017, @04:07PM

        by takyon (881) Subscriber Badge <reversethis-{gro ... s} {ta} {noykat}> on Wednesday August 30 2017, @04:07PM (#561548) Journal

        You're thinking of MDMA, the very drug this story is about. To counter that, you take 5-HTP [wikipedia.org] to restore serotonin levels.

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    • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @01:58PM (3 children)

      by Anonymous Coward on Wednesday August 30 2017, @01:58PM (#561502)

      In the 1980s, Leary became fascinated by computers, the Internet, and virtual reality. Leary proclaimed that "the PC is the LSD of the 1990s" and admonished bohemians to "turn on, boot up, jack in".

      Radical, man! What's his github, and I want to fork his repo.

      • (Score: 3, Interesting) by RamiK on Wednesday August 30 2017, @02:21PM (2 children)

        by RamiK (1813) on Wednesday August 30 2017, @02:21PM (#561508)

        This was years before personal computers. Not only was the hardware needed to run Unix too expensive to be within an individual's reach, but nobody imagined that would change in the foreseeable future. So Unix machines were only available by the grace of big organizations with big budgets: corporations, universities, government agencies. But use of these minicomputers was less regulated than the even-bigger mainframes, and Unix development rapidly took on a countercultural air. It was the early 1970s; the pioneering Unix programmers were shaggy hippies and hippie-wannabes. They delighted in playing with an operating system that not only offered them fascinating challenges at the leading edge of computer science, but also subverted all the technical assumptions and business practices that went with Big Computing. Card punches, COBOL, business suits, and batch IBM mainframes were the despised old wave; Unix hackers reveled in the sense that they were simultaneously building the future and flipping a finger at the system.

        http://www.faqs.org/docs/artu/ch02s01.html [faqs.org]

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        • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @02:35PM (1 child)

          by Anonymous Coward on Wednesday August 30 2017, @02:35PM (#561511)

          Linux is the establishment and systemd is the flipping finger. Countercultural enough for you?

          • (Score: 3, Insightful) by Anonymous Coward on Wednesday August 30 2017, @04:23PM

            by Anonymous Coward on Wednesday August 30 2017, @04:23PM (#561555)

            I realise that you're being jocular, but:

            honestly, systemd is more like the establishment trying to worm its way into Linux. "It's too hard for the Marketing department guys! Just ... make all that complexity go away! Like Microsoft!"

    • (Score: 2) by takyon on Wednesday August 30 2017, @04:42PM (2 children)

      by takyon (881) Subscriber Badge <reversethis-{gro ... s} {ta} {noykat}> on Wednesday August 30 2017, @04:42PM (#561566) Journal

      It could be used to treat depression and alcoholism. [theguardian.com]

      It's going to be slow going when it comes to getting any mainstream acceptance of hallucinogens. Many U.S. states and countries have legalized cannabis for medical purposes and that is still sitting on the joke that is Schedule I. LSD is too scary, see headlines like:

      Is marijuana really as dangerous as heroin and LSD? Finally, a welcome legal review [latimes.com]

      Marijuana remains a Schedule 1 drug - just like heroin and LSD - judge rules [dailynews.com]

      Look out for the "heroin and LSD" journalist meme when you read articles like this. You'll start seeing it a lot.

      As we should know by now, LSD is about as far away from dangerous as you can get [ias.org.uk]. Maybe you'll knock something over and get hurt. You probably won't jump out of a window.

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      • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @05:31PM (1 child)

        by Anonymous Coward on Wednesday August 30 2017, @05:31PM (#561594)

        As well it should. The burden of proof here is on the proponents to prove that the substance is safe enough and effective enough for a given use. We're long past the point where there was enough need for new treatments and a lack of resources for studying them.

        Ultimately, the people who claim without research to back it that these things are safe and effective are just as bad as the people who think we should ban all use, including research, without a body of evidence to point to.

        Alcoholism and such are serious issues, but they're also not completely without treatment available either.

        • (Score: 5, Informative) by takyon on Wednesday August 30 2017, @06:04PM

          by takyon (881) Subscriber Badge <reversethis-{gro ... s} {ta} {noykat}> on Wednesday August 30 2017, @06:04PM (#561614) Journal

          Schedule I is a research killer. [soylentnews.org]

          MAPS has been working with MDMA, LSD, psilocybin, etc. Very slowly. Because of the barriers to research that come with being on Schedule I. There have already been studies that have found evidence that LSD can be used as a treatment. Safety of LSD is well established.

          The Controlled Substances Act is unscientific. The Schedule I criteria are completely arbitrary.

          "The drug or other substance has a high potential for abuse." = anything they want it to mean.

          "The drug or other substance has no currently accepted medical use in treatment in the United States." = also broad enough to ignore accepted medical uses, and it's difficult to get additional research done because of Schedule I.

          "There is a lack of accepted safety for use of the drug or other substance under medical supervision." = anything they want it to mean.

          The burden of proof is for proponents to prove to the FDA that a drug can be a safe and effective treatment. The DEA and Controlled Substances Act are shit and should be eliminated. It would save money and lives.

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  • (Score: 2) by Snow on Wednesday August 30 2017, @03:17PM (10 children)

    by Snow (1601) Subscriber Badge on Wednesday August 30 2017, @03:17PM (#561528) Journal

    I did MDMA once. It was at some festival called Shambala in BC.

    It didn't really do anything for me. My wife did some as well and she was fucked up. She started hearing voices and said that everyone was shit-talking her behind her back (they weren't). It lasted for a couple weeks and we went to the doc over it. For like 2 weeks she couldn't even go to the supermarket. Thankfully it went away, but I was really worried for a while.

    It didn't really do anything for me though. I had a very faint headache/pleasure feeling, but nothing crazy. Felt like shit the next day though. Totally drained, both physically and emotionally. It was as if someone drained the life from me. Lasted for a couple days and then things were normal.

    That being said, I would definitely try it again given the right opportunity.

    • (Score: 2, Funny) by Anonymous Coward on Wednesday August 30 2017, @03:27PM

      by Anonymous Coward on Wednesday August 30 2017, @03:27PM (#561533)

      [quote]That being said, I would definitely try it again given the right opportunity.[/quote]

      "That being said"? That which was said has to be the worst supporting argument I've ever read.

    • (Score: 2) by Gaaark on Wednesday August 30 2017, @04:00PM

      by Gaaark (41) Subscriber Badge on Wednesday August 30 2017, @04:00PM (#561544) Homepage Journal

      The only time i smoked pot was in college: a viet nam vet grew his own (so i'm guessing not that strong). Shared a joint with him and 3 others.
      Felt NOTHING.
      He brought over another joint a day later and smoked it with me.
      Nothing.
      The next day, he brought over another with a ball of snot (he said was hash: i'm hoping it was NOT snot, lol) that he put into the joint.
      One puff and i was GONE.

      All i remember is having MAJOR MUNCHIES and eating $20 worth of crap (this would be mid-late 80's where $20 bought a crap load of crap-food: you could buy candies for 1cent).
      Felt awful after.

      That's why i stuck with alcohol.
      Now, gettting off the alcohol as well.

      --
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    • (Score: 3, Informative) by takyon on Wednesday August 30 2017, @04:29PM (3 children)

      by takyon (881) Subscriber Badge <reversethis-{gro ... s} {ta} {noykat}> on Wednesday August 30 2017, @04:29PM (#561556) Journal

      MDMA is notorious [hightimes.com] for being faked [stuff.co.nz] or mixed with other shit. That's not propaganda but on the ground reality, which has led to the emergence of testing on the scene at festivals [dancesafe.org]. You really don't know what you and your wife had (unless you really do). This is as good of a reason as any to say "I would definitely try it again given the right opportunity" since might not know if you did it a first time.

      LSD is also easy to fake since at least an order of magnitude more drug than needed can be fit onto a blotter and there are a family of compounds [wikipedia.org] that are very similar to LSD but with different total durations and dosages. It's hard to say that fake means bad here - if Albert Hofmann had synthesized a different chemical first, maybe that would be the drug of the 60s and the LSD molecule would be the unknown mimic drug. Whooooaaa, man. (Feel free to correct me if I'm wrong here. Maybe LSD is easier to synthesize than other similar drugs.)

      I imagine mushrooms or peyote would be hard to fake - as in substitute with another drug. However, my understanding is that peyote [wikipedia.org] takes years to grow from seed to fleshy cactus.

      Cannabis is probably not faked. It could be adulterated or sprayed with pesticides/etc., but the influx of legal options means that there is a lot of (government?) verified weed out there and at least some amount of the supply is "bespoke" organic weed made by people who are health conscious, opportunistic, or both.

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    • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @06:23PM (1 child)

      by Anonymous Coward on Wednesday August 30 2017, @06:23PM (#561627)

      She started hearing voices and said that everyone was shit-talking her behind her back (they weren't).

      I'm shit-talking you behind your back, Snow. This is AC talking. I'm always shit-talking you behind your back, Snow.

      • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @07:22PM

        by Anonymous Coward on Wednesday August 30 2017, @07:22PM (#561657)

        You now hear the screaming forever.

    • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @08:10PM

      by Anonymous Coward on Wednesday August 30 2017, @08:10PM (#561682)

      Apart from the reasons given by takyon, did you even do MDMA ("molly")? It's usually sold as small crystals of clear to brown-tinged colour, while Ecstasy/XTC is sold as pills. The crystal form of "molly" makes it hard as fuck to dose right, you can of course eyeball it by dipping your wet finger in it, but a precision scale is recommended - especially for a first-timer/casual user with low threshold/tolerance.

      Do you have an idea of how much you and your wife took? MDMA, while relatively safe, can be neurotoxic at very high levels. So while you may have gotten a typical effect for a first timer (none), maybe your wife had way too much?

    • (Score: 0) by Anonymous Coward on Thursday August 31 2017, @07:30PM

      by Anonymous Coward on Thursday August 31 2017, @07:30PM (#562264)

      y'all got some bullshit. probably wasn't even X from the symptoms you describe. try to get good shit next time, ffs.

  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @05:34PM

    by Anonymous Coward on Wednesday August 30 2017, @05:34PM (#561597)

    "MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct."

    This isn't likely to end like the opioid sad story which makes chronic addictions.

    This appears to be limited to 3 single doses as an aid to PTSD counseling.

    Additionally, the drug is a generic.

    Perhaps the FDA did a good thing?

  • (Score: 0) by Anonymous Coward on Thursday August 31 2017, @07:36PM

    by Anonymous Coward on Thursday August 31 2017, @07:36PM (#562269)

    mdma is pretty damn safe for the benefits it gives for ptsd/rape counseling. i wouldn't have waited on the fucking whores as the fda to use it for therapy, but at least they are finally doing something right.

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