🫠 This Week in Psychedelics

Welcome to Tricycle Day. We’re the psychedelics newsletter that’s always listening. Tell us how you really feel through the poll at the bottom of this email. ✍️

Here’s what we got this week.

Humans have been using psychedelics for millennia.

While the Horizons conference hasn’t been around that long, it is one of the longest-running in the field.

And the speaker list this year is stacked.

They’ve got the “psychedelics czar” of HHS, the CMOs of Compass and Definium, and the sweet-talkin' leader of the American ibogaine movement, to highlight just a few.

Horizons: Perspectives on Psychedelics brings all of these leaders (and more) together October 15-17 at the New York Academy of Medicine.

You don't get access to big brains like these every day.

Think outside the box: LSD and psilocybin, which are often grouped together, actually change brain activity in different ways.
Coming home: Psychedelics evoke a sense of familiarity, not unlike (but often more emotionally intense than) déjà vu.
Shrooms and legumes: Lifetime psychedelic use is associated with adopting a vegetarian diet.
Numb’s the word: Ketamine may provide greater neuropathic pain relief than lidocaine for some patients.
Count backwards from ten: Stanford researchers are testing an anesthesia-induced dreaming protocol as a more palatable alternative to classic psychedelic therapy.

Still in the saddle: Former CMO of Usona, Mike Davis, is keeping his spot as Director of the Center for Drug Evaluation and Research at the FDA.
Speaking of the FDA: The agency says it’s open to “innovative approaches” to clinical development of psychedelics drugs.
Get in line: HHS Secretary RFK Jr. believes there will be an “enormous demand” for psychedelic therapies as they become legally available.
Botanically correct: A new congressional bill could boost the development of plant-based medicines, including those derived from psychedelics.

Feeding time: Gilgamesh whetted Big Pharma’s billion-dollar appetite for psychedelics.
Change the tune: Compass Pathways launched a new disease education campaign to prime healthcare professionals for COMP360. (See previous coverage.)
Share the wealth: Compass also awarded grants to five organizations training healthcare providers to deliver psychedelic treatments.
Canada grown: Optimi Health is launching a Phase 2 clinical trial using its natural (non-synthetic) psilocybin in patients with depression.
Sure beats Silicon Valley: A European tech founder, who invented a new way to stabilize psilocin, is launching his next venture in Jamaica.

Thorny issue: Huachuma, the Andean psychedelic cactus, is attracting Western seekers and raising ethical questions.
Related: Drug-based rituals played a central role in the birth of Andean civilization.
Look book: See what people wore at Burning Man this year.
So easy a caveman could do it: Habitual use of a mind-altering plant medicine traces back at least 25,000 years.
Meme of the week: Humans really saw this and still decided to create Excel…

How often do you get the chance to tell the almighty powers-that-be how you think psychedelics should be regulated?

Not often. Not often at all.

But two days ago, a short list of psychedelics advocates (plus one unabashed critic) got to do just that.

The FDA just convened a four-hour public hearing, where 80 people delivered their most impassioned two-minute appeals to the agency (and the 1,000+ bystanders in person and online).

With so many insiders in attendance, some shilling of pet projects was to be expected. Not-so-hidden agendas aside, the commentary stayed fairly tight to the four pre-planned topics.

Surprisingly, the panel was speechless. While the array of microphones suggested there might be some back-and-forth, not one of the nine officials engaged in even the slightest banter.

Maybe they were dumbfounded. Maybe they were focused on listening. Maybe they were earnestly taking one commenter’s invitation to imagine what it would be like to be in that room on LSD.

In any case, we may have just witnessed the first government meeting in American history to end early. 🫠

Feels kinda weird to call two psychedelic companies “competitors.” (It’s all about connection and oneness, right?) So we’ll go with frenemies. Compass Pathways and Definium Therapeutics are probably the industry’s two most closely watched drug developers, working on psilocybin (COMP360) and LSD (DT120), respectively. This week, both posted big data wins as they race toward FDA approval.

Compass went first, with 52-week data from its Phase 3 COMP005 trial. Patients who took a second dose of COMP360 saw their depression scores drop 13 points from baseline, and the benefits held a full year later. These results build on the study’s initial readout (the first Phase 3 of any classic psychedelic, btw) which first separated psilocybin from placebo. Compass is still on track for a commercial launch in the first half of 2027, they say.

Definium, not to be overshadowed, answered a few days later with its third straight positive Phase 3 readout for DT120. This one showed a single 100-microgram dose cut anxiety scores 5.1 points more than placebo at 12 weeks. Stack that on Definium’s previous anxiety and depression results, and they’re three for three. But Compass shouldn’t be too salty. Every win legitimizes their category, too.

Colorado is a special place for mushroom lovers. It’s the only state that protects personal use (and gifting!) of psilocybin. But CO also has a regulated model, where licensed facilitators and centers are meant to operate. While Darren Lyman certainly isn’t the only person doing business in the gray zone, the state is making an example out of him. Though he’s not going down without a fight.

At his co-op, Lyman sells educational consults on dosing and integration. The mushrooms, he claims, are *ahem* a gift. Naturally, the state has sent multiple cease-and-desists accusing Lyman of unlicensed facilitation. Nevertheless, he’s kept doors open through clever workarounds. Now that a new law has closed the loophole he was slipping through, Lyman just sued DORA in federal court, asking a judge to freeze what he calls retaliatory enforcement while his case plays out.

Whatever the judge rules, this decision will draw a sharper line between personal and facilitated use than Colorado's ever had before. And right now, all we can think about is, man, if a single state can barely referee this fight, buckle up. Just wait till psychedelics go national.

That’s all for today, Cyclists! Whenever you’re ready, here’s how we can help.

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DISCLAIMER: This newsletter is for educational and informational purposes only and is not intended as a substitute for professional medical advice. The use, possession, and distribution of psychedelic drugs are illegal in most countries and may result in criminal prosecution.