🫠 This Week in Psychedelics

Welcome to Tricycle Day. We’re the psychedelics newsletter that thinks you should be able to experience ecstasy without breaking the law. Is that so much to ask?

Here’s what we got this week.

• MAPS’ MDMA results are in 💣

• Breaking down TREAT California 🍪

• The company mass-producing peyote 🌵

• How to launch your own psychedelic biz 🎙️

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RESEARCH

New MDMA study paves the way for FDA approval

Do you smell that, FDA? 👃 Mmhmm, that’s the scintillating aroma of soon-to-be-approved psychedelic medicine.

On Thursday, MAPS delivered the results from its second Phase 3 clinical trial of MDMA-assisted therapy for PTSD.

Not only did the study meet all its endpoints (or pre-specified goals). MAPS says with this win under their belt, the company’s on track to submit their New Drug Application later this year. 👀

Now here’s what you should know about the study.

• ✅ MDMA-assisted therapy clearly worked: 86% of the people who received MDMA improved their PTSD scores, and 72% no longer even qualified for a PTSD diagnosis.

• 💪 It built on earlier success: Another Phase 3 trial from MAPS from 2021 showed similar results. By the end of that study, 67% of the MDMA group were PTSD free.

• 🗣️ Don’t discount the talk therapy: Even the placebo group fared well. 69% of the people who “only” got the talk therapy improved their PTSD, and 48% no longer met the criteria for PTSD either.

• 🤎 Participants looked like real-world patients: 25%+ of the participants were Hispanic or Latino, and ~34% were nonwhite. MAPS made a concerted effort to include more than just “privileged people with lots of time and resources.”

If the regulators allow it, MDMA-assisted therapy would be the first real innovation in PTSD treatment in more than two decades. Then once it is approved, we can talk about putting MDMA in the water.

MICRODOSES

🤬 Inflammatory remarks: A new Beckley-backed study shows psilocybin reduces harmful inflammatory markers associated with stress-related disorders like depression, anxiety, and PTSD.

🧪 (Keep your) kool-aid acid test: MindMed has completed enrollment and dosing in its Phase 2 trial of LSD for generalized anxiety disorder.

👶 Baby blues: Using ketamine as an anesthetic during childbirth may help prevent postpartum depression, according to a new case study.

🇦🇺 Trouble down under: Research reveals Australian politicians, clinicians, and advocates are worried that psychedelic medicine has gotten ahead of the science.

POLICY

State analysts weigh in on TREAT California

California can’t stop, won’t stop with the psychedelic policy updates. This state’s making more moves than a VC who just got rained out of Burning Man.

Last week, we covered the decrim bill that’s awaiting the governor’s signature. Now, California’s Legislative Analyst’s Office (LAO) has posted a review of the (unrelated) TREAT California ballot initiative, which would set aside $5 billion generated from state bonds for psychedelic research and therapies.

TREAT California isn’t another decrim or legalization campaign. Instead, the proposed 2024 ballot initiative would create a new state agency called the TREAT Institute. Here’s what it would do.

• 💸 Distribute funding: They’ll dole out chunks of that $5B to universities, labs, and businesses to fund research into psychedelic medicine (both natural and synthetic).

• 📄 Seek FDA approval: When the research leads to exciting discoveries, they’ll work with the researchers to submit the therapies for regulatory review.

• 🤝 Set up IP agreements: Funding recipients will share intellectual property rights with the state of California, so the government gets a cut of revenue generated from successful R&D.

• 🧑‍🏫 Educate pros and the public: Not all of the $5B will go to research projects. They’ll also fund public awareness campaigns and training programs for professionals who want to administer psychedelic therapy.

Now $5 billion is nothing to sneeze at, even for a big ol’ state like California. In fact, the LAO crunched the numbers and found that the program will actually cost $6.6 billion after interest on the 30-year loans.

But the state could recoup those costs (and more) from the IP deals, not to mention potential Medi-Cal savings from disruptive psychedelic therapies.

Anyway, it’s up to California voters, not the LOA. But first, TREAT California will need close to a million signatures just to get on the ballot. Who’s got a pen? 🖊️ 

MICRODOSES

🏠 House rules: A Congressional committee has approved two psychedelic amendments for consideration on the House floor within a large Department of Defense bill.

☝️ No funny business: The US Office for Human Research Protections, a division of HHS, held a workshop on ethical considerations for psychedelic research.

🫸 Abate this: The Kentucky opioid commission is one step closer to investing millions in ibogaine research.

🇬🇧 Enough already: A committee of the UK Parliament recommends reforming the country’s Misuse of Drugs Act and rescheduling psychedelics to speed up clinical research.

👹 Dancing with the devil: A pro-life nonprofit says that the psychedelic decriminalization movement is “opening people up to demonic activity.”

BUSINESS

A publicly traded Canadian company is mass producing peyote

There’s one entheogenic plant that even the most progressive decrim advocates won’t touch. And it’s not because of its prickly spines.

Peyote (aka Lophophora williamsii) has been effectively off the table from policy reform because the mescaline-rich cactus is both endangered and central to many Native American spiritual traditions.

But Lophos Pharma, a company that just began trading on the Canadian Securities Exchange, is daring to go there. Here’s why:

• 👍 Unlike in the US, peyote is legal in Canada to grow, sell, and consume.

• ⏩ Normally peyote takes 16 years to mature, but they claim they can grow it in just 3 years.

• 🏭 By bringing cultivation indoors, they protect the plant from extinction and avoid ethical concerns.

The company is aiming to have dried peyote buttons for sale by next summer. After that? A whole peyote-derived wellness line, complete with microdosing capsules, transdermal patches, and sublingual strips, of course.

Aaaaand once again, The Simpsons eerily predicts the future.

MICRODOSES

⏱️ We’re still early: A market research firm predicts the psychedelics drug market will boom from $3 billion in 2022 to $12 billion by 2035.

🐂 Oregon trail-blazing: Oregon’s first licensed psilocybin service center has a 3,000+ person waitlist. Meanwhile, the state’s first legal psilocybin-assisted addiction recovery program has opened.

🌊 Ride the wave: Beckley Waves, a psychedelics-focused venture studio, has raised a $3.3 million fund to invest in startups expanding access to psychedelic therapies worldwide.

💰 Market mover: Billionaire Steve Cohen’s hedge fund Point 72 has purchased over 18 million shares of Cybin. The psychedelic biotech’s stock price surged on the news.

🐟 Swedish Phish: A Swedish nonprofit has launched a initiative to provide €3 million in funding for psychedelic research.

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Bicycle Day Anniversary Tee — The Chambers Project is a leading psychedelic art gallery based in Grass Valley, California. On top of showcasing some of the most influential contemporary artists in psychedelic culture, they also happen to have some pretty drippy merch. If this Tricycle Bicycle Day tee doesn’t get your wheels turning, check out their other designs.

Call for Mushroom Art — Attention creative fungiphiles: your artistic talent has been requested. Broccoli, the independent “publisher of unusual delights,” is foraging for mushroom illustrations, photographs, and other beautiful expressions to include in its forthcoming Mushroom People II print mag. Think you got what it takes? Submit your portfolio for consideration.

That’s all for today. Before you head off, don’t forget to share, rate, and review Tricycle Day below. Catch ya next time, Cyclists! ✌️

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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.