🫠 This Week in Psychedelics

PRESENTED BY ALTHEA & FOUNDATIONS 🤝

Welcome to Tricycle Day. We’re the psychedelics newsletter that would never email you a list of reasons you’re inadequate. All love from us. We wouldn’t make it as a three-letter agency, huh? 💌

Here’s what we got this week.

• MindMed’s LSD drug treats anxiety in one dose ☝️

• Psilocybin therapy is (probably) cost effective 💸

• FDA releases MDMA rejection letter to public 👀 

• Headgear for psychedelic nerds like us 🧢

FROM OUR SPONSORS

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MICRODOSES

🔬 Research

Going the distance: In a long-term study of psilocybin-assisted therapy for major depression, 67% of participants were still in remission five years after treatment.
Grief relief: Ayahuasca-assisted meaning reconstruction therapy helped people with prolonged grief disorder after the death of a loved one.
Steady as she goes: A review of substance use disorder studies concluded that psychedelics may balance dopamine levels in the brain, reducing cravings and relapse.
Cool your jets, man: Psychedelic-derived compounds could be the next class of anti-inflammatory therapies.
Seeking volunteers: Open Psychedelic Evaluation Nexus is enrolling both facilitators and their clients for a study on the long-term effects of psychedelic services.

🏛️ Policy

Pure awareness: HHS Secretary RFK Jr. told the governor of Colorado he’s aware of the state’s natural medicine program and will keep advocating for psychedelic therapy.
Racing the clock: Natural Medicine Alaska is on track to collect the 35,000 signatures required to submit their ballot initiative before January.
Freedom of assembly: The legal battle between University of Michigan and a student group organizing a psychedelic festival is headed to a new court.
Data dump: Oregon Psilocybin Services released their Q2 session data and a new archive of past reports.
Continental drift: Europe is going through a breakthrough in access to psychedelic therapies.

📈 Business

Out with the old: The (former) CEO of Cybin has stepped down.
In with the new: MAPS has two new Co-Executive Directors.
Open book: Compass Pathways published results from their open-label Phase 2 study of psilocybin for PTSD.
Development down under: PharmAla Biotech spun out a subsidiary to conduct clinical research in Australia.
A rising tide lifts all centers: Oregon economists predict the number of legal psilocybin sessions will double over the next two years.

🫠 Just for fun

Tackling trauma: Former NFL All-Pros are turning to psychedelics to heal their brains.
Hikrodosing gone wrong: Four hikers were rescued from the Catskills after getting lost on a mushroom trip.
Beauty is in the eye of the journeyer: Psychedelics can help us understand how the brain interprets aesthetics.
Meme of the week: You can’t make mushrooms your entire personality… or can you?

THE PEAK EXPERIENCE

No more chill pills

Remember when your biggest anxiety was whether you'd fed your Tamagotchi?

Simpler times. (RIP, Sparky.)

These days, ~1 in 10 people deal with generalized anxiety disorder (GAD). That’s the clinical term for that relentless state of worry that makes your brain feel like a browser with 47 tabs open.

But MindMed has some promising news for our friends with overstimulated nervous systems. Their Phase 2b trial of MM120 (a proprietary form of LSD) showed that a single dose can significantly reduce GAD symptoms for up to three months.

Here's what happened when 198 people with moderate-to-severe GAD got their dose.

• 🍬 Sweet spot: Researchers identified 100 μg as the Goldilocks dose. Not too weak, not too intense.

• 📉 Quick relief: Anxiety scores dropped significantly within 24 hours and stayed low for 12 weeks.

• 🙌 High success rate: 65% of people who got the optimal dose showed a response (a 50%+ reduction in anxiety). 47% hit full remission.

• 💖 Depression bonus: The treatment also knocked down depressive symptoms, which tend to tag along with GAD.

Unlike other psychedelic studies that have combined medicine with intensive therapy, this trial kept it simple. Participants had their experience in a pleasant room with music and eyeshades, monitored by trained staff who explicitly weren't doing therapy.

The idea was to isolate the drug's effects from any psychotherapy benefits, since that was such a major FDA concern in last year’s MDMA rejection. (More on that in a minute.)

For those keeping track at home, MM120 would be the first novel anxiety treatment approved since 2007, and the FDA has already given it breakthrough therapy status.

If the Phase 3 trials pan out, we could finally get an anxiety medicine that a) works and b) doesn't require you to remember to take a pill every morning.

People with GAD have enough to worry about already, don’t you think? 🫠

AFTERGLOW

Show me the money

Researchers just crunched the numbers on psilocybin-assisted therapy for treatment-resistant depression, and the verdict is… cautiously optimistic. If the price is right, that is. A new cost-effectiveness analysis found that PAT could deliver economic value at $5,000 per treatment, with a ~75% chance of being cost-effective compared to the standard of care. But bump that price to $10k and the probability plummets to 1%. (Eek.)

This study modeled PAT as a third-line treatment for people who'd already failed (/been failed by?) two other therapies. While psilocybin showed modest health gains over 12 months, it also cost about $3,600 more than typical care. That works out to roughly $117,000 per quality-adjusted life year, which squeaks under the $150,000 threshold that health economists use to determine value.

The reason this matters is, cost-effectiveness analyses often influence insurance coverage decisions. All those prep, dosing, and integration sessions administered by trained pros aren’t cheap. (Daily antidepressants, on the other hand…) So, for the millions of depressed Americans who've run out of options, the economic case for psilocybin therapy is building. But if the math ain’t mathin’, we’ve got an issue.

MDMA post-mortem

A year and change later, the FDA just made its Complete Response Letter to Lykos Therapeutics public. To everyone who was hoping for better news back in August ‘24, sorry to salt the wound. But hey, at least now we know exactly why MDMA-assisted therapy got the thumbs down. The 10-page document spells out three major stumbling blocks that the whole psychedelic industry can learn from.

First, Lykos didn't track "desirable” side effects like euphoria. Second, they only followed participants for 8 weeks post-treatment. And third, they enrolled way too many people with prior MDMA experience. 40% of participants had used MDMA before, which is double what you'd expect in the general PTSD population. According to the FDA, that created an expectation bias and made it harder to know if the results would apply to everyone else.

If there’s a silver lining, it’s transparency. Until now, Complete Response Letters have been kept confidential, but the FDA released 89 of them as part of a new openness push. Lykos err, Resilient Pharmaceuticals (oops, still adjusting to the name change) has until August 2025 to respond. Though if they need new studies, it’s gonna be a while before MDMA therapy comes out of the underground.

CYCLISTS’ PICKS

• 🧢 Merch: Our friends at Psychedelic Alpha just dropped a collection of embroidered caps that’ll make any psychedelics insider snort-laugh.

• 🎟️ Giveaway: Enter PORTAL’s latest sweepstakes for a chance to win an all-expenses-paid 5-night psilocybin retreat in Jamaica hosted by Beckley Retreats.

• 👩‍💻 Webinar: Mind Medicine Australia (not to be confused with MindMed) is hosting the godfather of microdosing himself, Jim Fadiman, for a free educational webinar.

• 🤝 Networking event: The Psychedelic Professionals Networking Club is back for another evening of debauchery curated conversations with fellow industry folks, old and new. Register for $5 with code TRICYCLE.

UNTIL NEXT TIME

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

ONE CYCLIST’S REVIEW

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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.