FDA Designates MM120 (LSD) Breakthrough Therapy for Generalized Anxiety Disorder

https://www.businesswire.com/news/home/20240307733599/en/MindMed-Receives-FDA-Breakthrough-Therapy-Designation-and-Announces-Positive-12-Week-Durability-Data-From-Phase-2B-Study-of-MM120-for-Generalized-Anxiety-Disorder

by beefman • 2 years ago

122 64 2 years ago

businesswire.com

radicaldreamer2• 2 years ago

Truly 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• 2 years ago

which startups?

radicaldreamer2• 2 years ago

Good list here: https://psychedelicalpha.com/data/psychedelic-drug-developme...

tomComb• 2 years ago

In this case it is a company called mind medicine.

zoklet-enjoyer2• 2 years ago

MDMA isn't psychedelic. Or maybe I never took enough

canadiantim3• 2 years ago

It 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.

drooby• 2 years ago

In 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.

canadiantim3• 2 years ago

Don'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-land3• 2 years ago

How 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?

DenisM2• 2 years 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

(X) “how to change your mind” documentary (Netflix)

AnthonBerg• 2 years ago

As 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

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.

LoganDark6• 2 years ago

This 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• 2 years ago

I 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• 2 years ago

I'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• 2 years ago

Same as Ketamine. Ketamine therapy is available now but, the cost very high so, it is practically unavailable to most.

sva_• 2 years ago

I'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.

DenisM2• 2 years ago

I wonder what is the significance of it being a salt rather than a pure lsd?

For d-amphetamine making it a salt produces an effect similar to delayed release. The result is sold as a “more modern” ADHD treatment Vyvanse.

So is this achieving similar effect? Flattening the curve, so to speak?

Or maybe it’s just to distance itself from the recreational LSD culture?

isoprophlex• 2 years ago

Usually these salts remain chemically stable for longer periods of time. In the case of alkaloids, they become protonated (here LSD-with-a-proton, a positively charged particle; the tartrate being the negative counterion) and as such are thus less susceptible to oxidation. Can't steal negative charge from something that doesn't have it.

And with LSD freebase that's not an unnecessary luxury, as it isn't the most stable against decomposition. To answer the question... probably this is the most stable formulation to get it into a pharmacy? I guess like you say, not blatantly calling it LSD helps image building too.

With vyvanse, that's actually something else: not a salt but an amino acid covalently bound to amphetamine. This gives a much stronger bond than between tartrate and lsd ions in the salt, one that can be hydrolysed slowly in the gut to produce the active drug. LSD tartrate doesn't have a similar slow release property.

0cf8612b2e1e• 2 years ago

If nothing else, by being chemically distinct from LSD, it remains a crime to have LSD, but not the salt prescription form.

jdietrich3• 2 years ago

I wonder what is the significance of it being a salt rather than a pure lsd?

The salt is patentable.

philwelch2• 2 years ago

Adderall and Dexedrine are already amphetamine salts. Vyvanse has an extra delayed release mechanism beyond that.

Scoundreller• 2 years ago

The API in Vyvanase isn't a salt of straight amphetamine though. It has a covalent bond to a group that your body/metabolism needs to (I guess enzymatically) break down to release the amphetamine. More of a prodrug.

pazimzadeh• 2 years ago

probably allows it to be patented

croemer• 2 years ago

What is the impact of something being designated a breakthrough by FDA? What changes as a result?

elektor• 2 years ago

The 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.

nukeyoular4• 2 years ago

I can get LSD25 on a casual walk on Haight st. on a Tuesday. Excuse my French here, but fuck the FDA.

CPLX• 2 years ago

What could possibly go wrong with this approach to drug distribution? It seems perfect from a policy perspective.

nukeyoular4• 2 years ago

A 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.

LoganDark6• 2 years ago

I would love for it to be better, but isn't LSD a chief victim of the war on drugs (other than fentanyl)? There's no way that there are going to be clean, quality-controlled sources of it any time soon. After all, it's a dangerous hallucinogen, and it's equally dangerous for everyone. Just like how alcohol and nicotine are equally safe for everyone.

I say this as someone who's had high doses of LSD25 before and failed to hallucinate much if at all. I don't doubt that people can, but not everyone does.

(I support decriminalization, but I want safe regulated sources to be freely available. People shouldn't have to resort to the dark web or to random dealers on the street. People should have sources that are guaranteed safe, just like other supplements.)

philwelch2• 2 years ago

With psychedelics in particular, I honestly think a lot more can go wrong by trying to shoehorn them into the medical system as it exists today. You’re talking about something that’s close to a spiritual experience and you think you’re going to do it justice by forcing it through the machine of HMO’s and corporate medical practices?

akira2501• 2 years ago

"Oh, you have Generalized Anxiety Disorder? Just take a casual walk down Haight street and try to purchase one specific drug from the random 'vendors' there."

Thanks, Doctor!

nukeyoular4• 2 years ago

I can decide to do LSD on my own without asking for permission from another man.

cpncrunch• 2 years ago

It'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-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• 2 years 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• 2 years ago

Ketamine is an anesthetic. Seems like the study raises serious questions about efficacy.

jdietrich3• 2 years ago

(see for example the recent study showing no difference to placebo for ketamine under anaesthetic)

Ketamine is an anaesthetic and has the same mechanism of action as inhalational anaesthetics. A trial of ketamine+anaesthetic vs placebo+anaesthetic might indicate that ketamine is no better than placebo, but equally it could indicate that general anaesthesia is an effective antidepressant. Your NMDA receptors don't particularly care whether they're being antagonised by ketamine, nitrous oxide or isoflurane.

https://www.nature.com/articles/s44220-023-00140-x

WarOnPrivacy• 2 years ago

It's just a press release [and seemingly not] beyond what was published in December

Stock spike on Thru but not Dec (to <$10/share). The 6 mos trend might support what you're saying tho. Also, me ! a $ wonk.

ref:https://www.marketwatch.com/story/mindmeds-stock-jumps-24-af...

bufferoverflow• 2 years 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"

LoganDark6• 2 years ago

I 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...

FDA Designates MM120 (LSD) Breakthrough Therapy for Generalized Anxiety Disorder

Related Stories