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Everybody’s Happy Nowadays


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2025 Jun 23, 5:06am   158 views  13 comments

by Al_Sharpton_for_President   ➕follow (5)   ignore (6)  

Compass claims Phase 3 win in depression for psilocybin drug, moves closer to FDA filing

Compass Pathways said Monday its psilocybin drug has cleared the first of two late-stage tests in a challenging form of depression as it advances toward the potential of becoming the first classical psychedelic on the market.

Patients treated with Compass’ COMP360 in a Phase 3 trial saw an average 3.6-point improvement on a depression symptom rating scale called the Montgomery-Åsberg Depression Rating Scale at six weeks versus placebo. Compass said Monday the result is both “statistically significant” and “clinically meaningful.”

Jefferies analyst Andrew Tsai previously told Endpoints News that a two-point difference is enough to secure FDA approval.

But in a previous interview with Endpoints, Compass’ former chief medical officer and now HMNC Brain Health CMO Hans Eriksson said most clinicians would want to see a minimum four-point difference.

The Phase 3 COMP005 trial enrolled over 250 people with treatment-resistant depression (TRD) across 32 sites in the US. The study looked at the effects of a single 25 mg dose of COMP360, which contains a synthetic version of the hallucinogenic compound found in magic mushrooms.

Compass plans to discuss the primary endpoint data with the FDA, but does not intend to file for approval until a second Phase 3 study reads out next year. That trial is testing three separate doses of COMP360 administered twice — including a sub-therapeutic 1 mg dose — in more than 550 patients with TRD.

An independent data safety monitoring board said there have been no unexpected safety findings or “clinically meaningful imbalances” in suicidality between arms across the two Phase 3 trials so far.

But getting the green light from regulators is just the first in a series of hurdles for COMP360. The drug’s commercial rollout and reimbursement prospects could present another challenge due to its high burden of administration. COMP360 treatment requires supervision by a healthcare professional for six to eight hours, as well as preparatory and integrative sessions.

Compass has said it plans to leverage the roughly 5,500 psychiatric treatment sites in the US that administer Johnson & Johnson’s ketamine-based depression treatment Spravato. But even that plan has its limitations, because Spravato only requires around two hours of supervision.

Meanwhile, the broader psychedelics field has attracted a recent boost in support from key figures in the Trump administration, including HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. It has also started to see some consolidation, with atai Life Sciences and Beckley Psytech announcing plans to merge earlier this month.

https://endpoints.news/compass-reports-phase-3-depression-data-for-psilocybin-drug/


Comments 1 - 13 of 13        Search these comments

1   clambo   2025 Jun 23, 7:02am  

I guess drugs are good when religion takes too much effort; like taking a shower, getting dressed, driving to church to be enthralled by some bullshit preacher.

Jimi was my idol once upon a time, he was great.
2   WookieMan   2025 Jun 23, 7:16am  

I have no problem with it. Did it last summer for the first time in a while. It was free. I said I'd only take two and the guy we were camping with said that was not enough (chocolates). I'm like fine 8. Everyone was zombies. I was as usual nauseous for the for 30-45 minutes.

Settled down and it was fun, but I don't think everyone else handled it well. Like I said zombies. Don't white water raft in the sun for 2 hours drinking and then think mushrooms are a good idea. I sat with the only person that didn't take any and conversed with her once my stomach was settled. Everyone was just literally laying in their tents and hammock tripping.

While not having a problem with it, I don't think it's a good thing to make available to the public. Obviously it's around, but I know people that if they take it they're fucked on low doses. My mom and sister started taking edibles (weed). They go full retard. This stuff is getting mad powerful and I can't image with shrooms how much commercially approved stuff would be. I stopped smoking weed when I had the legal stuff.

If you don't start out slow you're in for a shit storm that isn't fun with shrooms. I want LSD legalized. That's a maximum upper at the right dose and I don't think does anything to the body at all. Just had one blotter and was in probably the best mood of my life. Can't explain it. I don't hallucinate, I buzz on those types of drugs. Beer is my only vice though now. No pills, drugs, nothing. I feel good.
3   Patrick   2025 Jun 23, 10:50am  

Al_Sharpton_for_President says

But getting the green light from regulators is just the first in a series of hurdles for COMP360.


The biggest hurdle will be ensuring profitability of something which occurs in nature and is extremely cheap to make.

The way our FDA works, profitability for Big Pharma is essentially the only consideration in the approval process. This is why the FDA had such a problem with truly safe and effective ivermectin. No one could make any money with it, and it was cutting into mRNA death jab revenue.
4   Al_Sharpton_for_President   2025 Jun 23, 11:30am  

Whenever I’d buy shrooms, there was a nagging concern about potential toxicity. How credible is the dealer? How good is his supply? I used to buy them from an “art dealer” in SF, and they were always good, but still. I think some guarantee of safety and potency, based upon a logical QA/QC testing process, would add value.
5   Ceffer   2025 Jun 23, 12:11pm  

How many posts around here are made while shrooming? I thought alcohol and pot were the prevailing lubricants.
6   WookieMan   2025 Jun 23, 12:22pm  

Al_Sharpton_for_President says

I think some guarantee of safety and potency, based upon a logical QA/QC testing process, would add value.

Don't deny that. As someone that's used a lot of it, it's just not necessary to be legal. I've seen too many people not handle it or overdid it. I'd rather see drunk divers on the road than shoomers. 90% of the problem with drinking is no one cuts anyone off.

When I get cut off from booze I stop and lay down. Once a decade maybe. No one has a clue how much you're tripping, they can see the cans consumed. So friends can't help you if they're doing the same thing. I've done shrooms and LSD at the same time. I got in a police chase on the way home (not really). Got home my dad thought he was sick. Asked if I feel if his head was warm. Managed it well, I don't know if it was real to this day though.

Top 3 dumbest nights of my life.
7   Al_Sharpton_for_President   2025 Jun 23, 1:27pm  

WookieMan says


When I get cut off from booze I stop and lay down.

I am mostly a wino nowadays. One glass a night with dinner. My weapon of choice is sauvignon blanc, especially from New Zealand. Although I loves the reds, too, it tends to put me to sleep more than whites. Thankfully I can buy decent cheap wine at Costco. In Maryland, fuggedaboudit. Sadly I cannot have beer. I used to love to drink dark beer but I have gout and beer is loaded with purines. Never was into hard liquor. Dolor de cabeza, blow chunks if over-indulging.
8   Patrick   2025 Jun 23, 1:38pm  

Yes, Kono from NZ is good. Problem there is that it's too easy for me to finish the bottle instead of having just one glass.

Lately my wife and I have been having a drink make from equal parts Napoleon brandy from TJ, cranberry juice, and sparkling water at 5pm. Not sure what to call it, but it's good, and somehow I'm not tempted to have a second one.
10   WookieMan   2025 Jul 10, 5:54am  

Al_Sharpton_for_President says

I am mostly a wino nowadays. One glass a night with dinner. My weapon of choice is sauvignon blanc, especially from New Zealand.

lol, you sound like my mother in law. She gets pissed when we go out and the place doesn't have a New Zealand sauvignon blanc. Legit she'll be like F this place lets go. She's a handful.

But I do get people liking their drink of choice. I'm a cheap, low alcohol date and low maintenance. Light beer. I'm 220lbs currently so I barely get a buzz after 3. A whole bottle of wine for whatever reason I'd become a terrorist ass hole. Hard liquor I wouldn't be typing this, I'd be dead and almost died around 19 from it. Stopped since then. Occasional celebratory shot 3-5 times a year, one and that's it.

I try not to have too much beer though. I can pee at 10pm, go to sleep and I'll have to pee 2-3 times overnight without anymore fluids. I should probably get a full check up. Have some worries with liquid retention/kidneys. We'll see. That's why I post at random times overnight. Pee and sit down and knock out 2-3 comments here and then go back to sleep.
11   Al_Sharpton_for_President   2025 Jul 10, 6:03am  

Yeah, I used to love da beers, especially dark beer, stout, but it has significant purine levels, so a person with gout has to stay away. Sardines, anchovies, shellfish, herring - no can do. So I am a wino by default. I’ve controlled my gout by watching what I eat. A doctor that I first went to said let me put you on these pills, and you can eat anything you want. Err, no thanks.

I’ve run the reds gamut, especilly Italian wines, but they generally put me to sleep so I stick with whites. I do like a decent chardonnay, but yeah, sauvingon blancs are my fave. I can relate to your MIL’s reaction. I once went to a well-regarded burger joint and all they had was Pinot Grigio and Rose'. I’m outta here.
12   WookieMan   2025 Jul 10, 6:59am  

Al_Sharpton_for_President says

I’ve run the reds gamut, especilly Italian wines, but they generally put me to sleep so I stick with whites. I do like a decent chardonnay, but yeah, sauvingon blancs are my fave. I can relate to your MIL’s reaction. I once went to a well-regarded burger joint and all they had was Pinot Grigio and Rose'. I’m outta here.

I love red wines for a specific reason, as you mention, they put you to sleep. Weddings that I can't stand I'll drink the reds and go back to the hotel or room early because I don't like the people there. Made my appearance, not dancing and doing the bull shit.

I also hate loud music. Can't hear other people as a drummer with ear damage. No point in being there if we can't converse. So I drink the red. I have no clue if it's shit or good. Probably shit. Have a beer or two in the room and go to sleep.
13   Al_Sharpton_for_President   2025 Jul 10, 7:04am  

Whenever I go to a concert, I wear noise canceling ear plugs. Back in the day, I attended a Hot Tuna concert at the New York Academy of Music. We sat way near the stage, may 2nd row, can’t remember. And they played, and played, and played. Really, really loud. Afterwards, I couldn’t hear the subway coming on the platform.

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