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FDA Designates MM120 (LSD) Breakthrough Therapy for Generalized Anxiety Disorder
- radicaldreamer 3y agoTruly excellent news… we’re now at 3 psychedelics given breakthrough designation by the FDA for different mental health indications: MDMA (ptsd), psilocybin (depression, anxiety), LSD There are startups testing 2CB, DMT and some more exotic psychedelics for various indications as well.
- j4hdufd8 3y agowhich startups?
- radicaldreamer 3y agoGood list here: https://psychedelicalpha.com/data/psychedelic-drug-development-tracker https://psychedelicalpha.com/data/psychedelic-drug-developme...
- tsoernes 3y agoThere's no mention of 2-CB in that list
- DoodahMan 3y agohttps://psychedelicalpha.com/wp-content/uploads/2023/02/Psychedelic-Drug-Development-Bullseye-Chart.pdf https://psychedelicalpha.com/wp-content/uploads/2023/02/Psyc... may be a better reference. for example, though not specified as 2C-B, Arcadia Medicine's AM-1002 (PTSD) is a phenethylamine.
- tomComb 3y agoIn this case it is a company called mind medicine.
- zoklet-enjoyer 3y agoMDMA isn't psychedelic. Or maybe I never took enough
- canadiantim 3y agoIt can be, for sure, but there's also so many different kinds that are sold as MDMA when it's actually a very similar but slightly different molecule.
- zoklet-enjoyer 3y agoBack in the day, I could get pure MDMA and several cathinones. I preferred methylone over MDMA
- devin 3y agoNot sure why you were downvoted. It’s well known that MDA is frequently sold as MDMA.
- drooby 3y agoIn my experience, it fits the definition. On higher doses of MDMA I experience mild to moderate closed eye hallucinations when listening to music (morphing shapes). Though I have never had open-eyed hallucinations to any degree. And I would absolutely define it as "consciousness expanding" in the sense that having conversations with friends while under its influence opens up aspects of my emotional mind that are very difficult for me to uncover while sober.
- canadiantim 3y agoDon't forget Ketamine. It's truly remarkable for depression and PTSD, arguably better than mdma or psilocybin because it's not as psychadelic but produces profound effects regardless. I took my mom to a ketamine clinic recently and up till then my biggest concern for her health was that she was always stuck in fight or flight, constant 11/10 stress levels, what I would call PTSD or complex PTSD. Anyway, after just 1 visit to ketamine clinic (2 low-medium dose sessions only), she's completely cured of her stress disorder. It's remarkable. This was a long-standing pattern for my mom and ketamine (with the help and guidance of an incredible therapist too) fixed it in a weekend, basically.
- noman-land 3y agoHow does it actually work? Ketamine is a tranquilizer, right? Is it like a therapy session you do using Ketamine to turn off your stress so you can think clearly? How does it have lasting effects?
- fragmede 3y agoI can't speak for GP, but when it's combined with talk therapy, the ketamine allows the body to lower its defenses so that talk therapy can more successfully be administered, and the combination of the two is what leads to long lasting effects, long after the ketamine has worn off. Ketamine let's the patient open up so talk therapy can get at the underlying issue and resolve that, in ways that talk therapy alone can't solve because the patient's flight /fight response/anxiety won't let them let their guard down to really talk about it.
- DenisM 3y ago> did not receive any form of study-related psychotherapy for the duration of their participation in the study This is remarkable - IIRC previous studies (X) involved additional psychotherapy, and quite extensively. (X) Huberman Labs. https://youtu.be/fcxjwA4C4Cw?feature=shared https://youtu.be/fcxjwA4C4Cw?feature=shared (X) “how to change your mind” documentary (Netflix)
- AnthonBerg 3y agoAs I understand it, the reasons for it working by itself are described here: “Psychedelics and Immunomodulation: Novel Approaches and Therapeutic Opportunities“, A. Szabo (2015). https://doi.org/10.3389%2Ffimmu.2015.00358 https://doi.org/10.3389%2Ffimmu.2015.00358 Central nervous system inflammation does not feel good. There are many, many known links between mental or emotional ills and inflammation. All the classical serotonin receptor 5-HT2A-activating psychedelics as well as MDMA are profoundly immunomodulatory. They reduce inflammation.
- LoganDark 3y agoThis is great news. I believe in the possible utility of LSD without requiring professional/clinical supervision. I've used it at home quite a bit in the past and it's been extremely useful for processing emotions and trauma, as well as helping calm me down in general. I'm neurodivergent, so it most definitely doesn't work this way for everyone, but it's extremely helpful for me and I hope that one day the law recognizes that.
- zoba 3y agoI was wondering if MM120 is actually LSD (why the special name if so?) and found this on another source: > MM120 is a tartrate salt form of lysergide, a semi-synthetic hallucinogen commonly known as LSD
- csdvrx 3y agoI'm afraid it will be sold at a price most will not be able to afford, especially without health insurance. I'd support decriminalization efforts instead: we let people with cancer get weed from a dispensary. Why not let veterans and other people with a generalized anxiety disorder get LSD the same way?
- fnordfnordfnord 3y agoSame as Ketamine. Ketamine therapy is available now but, the cost very high so, it is practically unavailable to most.
- sva_ 3y agoI'm generally in favor of letting (healthy) adults decide what they consume (in particular hallucinogens), but I'm not sure it is a good idea to just hand them out to people with real psychiatric disorders without any therapeutic guidance.
- evilDagmar 3y agoI wouldn't even hand it to normal, "stable" people without some guidance. Not everyone handles losing their marbles with grace and aplomb. It's not in the average person's skillset to be able to say, "it's just the drugs" and keep their cool.
- LoganDark 3y agoOne of the other reasons not to give it out freely is that it varies wildly in effect depending on who exactly takes it. I certainly don't lose my marbles when I'm on it, but plenty of people have lost their sanity from it, sometimes for months, years or even life. Not to mention HPPD can sometimes appear, ranging from just "weird" all the way to distressing or madness-inducing.
- croemer 3y agoWhat is the impact of something being designated a breakthrough by FDA? What changes as a result?
- elektor 3y agoThe drug gets expedited review and increased assistance from the FDA. It's a good thing to have if you're trying to get it on the US market.
- nukeyoular 3y agoI can get LSD25 on a casual walk on Haight st. on a Tuesday. Excuse my French here, but fuck the FDA.
- CPLX 3y agoWhat could possibly go wrong with this approach to drug distribution? It seems perfect from a policy perspective.
- nukeyoular 3y agoA lot could go wrong but in San Francisco I'm not really worried about it. If you're really concerned, just make sure your DNM vendor has consistently good user reviews. I unironically trust random weirdos on Haight st and DNM vendors than the federal government. While grandpa Joe's recent campaign speech was very inspiring, there's a very very long way to go before I can ever remotely trust the FDA again.
- chpatrick 3y agoYou know LSD was discovered by big pharma right (Sandoz)?
- nukeyoular 3y agoYou post like FDA and "big pharma" are one and the same.
- heisenbit 3y agoThis is a good question. Is a paperwork oriented regulatory regime supportive of formation of mega corps?
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- LoganDark 3y ago
- cpncrunch 3y agoIt's just a press release, and it looks like they haven't released anything beyond what was published in another press release in December: https://www.clinicaltrialsarena.com/news/mindmed-trial-anxiety-disorder/?cf-view https://www.clinicaltrialsarena.com/news/mindmed-trial-anxie... Still no study published, no information about blinding effectiveness. It does say that adverse events include hallucinations, which doesn't bode well for effective blinding. So far there isn't really any strong evidence that hallucinogens including ketamine are more effective than placebo at relieving anxiety or depression (see for example the recent study showing no difference to placebo for ketamine under anaesthetic), even though we all strongly wish they were.
- swatcoder 3y ago> see for example the recent study showing no difference to placebo for ketamine under anaesthetic That's not counterevidence to ketamine's efficacy, it's evidence that the efficacy, if prior studies soundly demonstrated it, relies somehow on the user not being anesthetized during the treatment. I don't think that surprises many advocates of psychodelic or hallucinogenic therapies. And these are not the first class of treatments where blinding isn't practical. It does confound some forms of analysis when you can't acheive real blinding, but we've devised many alternative forms of analysis that we take as scientifically "good enough" to treat something as medicine.
- WhitneyLand 3y agoKetamine is an anesthetic. Seems like the study raises serious questions about efficacy.
- sterlind 3y agoKetamine is a dissociative that's used as an anesthetic. General anesthesia is a different beast. The precise mechanism GAs use isn't understood, but they cause slow waves of electrical activity to wash over the brain, constantly resetting neural networks and preventing communication, leading to coma. This includes breathing, which is why the patient needs to be intubated. Ketamine doesn't stop respiration. It causes profound dissociation and hallucinations, but I don't think it causes coma. It's definitely doing different things than GAs, at least. So it doesn't seem unreasonable that ketamine wouldn't work if you're in a coma. I'd be surprised if LSD did either. Or anything, for that matter. There's not a lot metabolically happening in a neuron under coma.
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- bufferoverflow 3y ago"The most common adverse events (at least 10% incidence in the high dose groups) on dosing day included illusion, hallucinations, euphoric mood, anxiety (LOL), abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis"
- LoganDark 3y agoI want to hope that one day I'll be able to buy this stuff and take it home, but I know that there are many more years and trials necessary to prove that it's safe. It's not safe for everybody and full legality will probably have to wait until they've figured out a really solid set of contraindicators...