🫠 This Week in Psychedelics

[4-min read] MAPS PBC submits New Drug Application for MDMA.

Welcome to Tricycle Day. We’re the MDMA of newsletters. We open up your heart and help you better relate to the past… the past week in psychedelic news, at least.

Here’s what we got this week.

  • Psilocybin for bipolar II disorder 🎭

  • MDMA submitted for FDA approval 💗 

  • Psychedelics in the defense bill 🪖

  • A visual history of shrooms 🍄 

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MICRODOSES
🔬 Research

Just a lil’ bit: A new study suggests microdosing LSD lifts people’s moods.
Hurry up: Gilgamesh will launch a Phase 2 trial of its fast-acting psychedelic in the new year.
Nose candy: Clearmind’s psychedelic molecule, MEAI, may help treat cocaine addiction.
MDMA 2.0: Transcend Therapeutics shared promising data from its trial of an MDMA analog for PTSD.
You’re not tripping: Delix’s non-hallucinogenic “neuroplastogen” was safe and well tolerated in its first human trial.

🏛️ Policy

Pushing the limits: An opinion in JAMA warns that state-regulated psychedelic models are asking for trouble.
For medicinal use: A California campaign has finalized its 2024 ballot proposal, which would give doctors the right to recommend psychedelics.
Never give up: Connecticut lawmakers are taking another shot at decriminalizing mushrooms.

📈 Business

Mushroom IP: Cybin and Terran Biosciences both won new psilocybin patents.
Network effects: ATMA and Cena Life have launched a Psychedelic-Assisted Therapy Healthcare Network across Canada.
Toad medicine: Alvarius has raised €5.5 million to commercialize 5-MeO-DMT for addiction treatment.
Exit strategy: Exopharm has agreed to acquire Tryp Therapeutics.

🫠 Just for fun

To die or not to die: Psychedelics and longevity are long-lost best friends.
Watch your back: Bufo alvarius hunters are under attack by Mexican cartels.
Meme of the week: A profound and beautiful trip

THE PEAK EXPERIENCE
Emotional rollercoaster

Enough is enough, mood swings

Life is full of ups and downs, no matter who you are. But for folks with bipolar II disorder (BDII), a condition marked by cyclical episodes of depression and mania, it’s more like a rollercoaster of emotions you can never get off.

But what if psychedelics are the mood stabilizers that we’ve been missing? A new study has found that a single dose of psilocybin, combined with psychotherapy, brought patients with treatment-resistant BDII lasting relief from their depressive symptoms.

The trial, sponsored by COMPASS Pathways, followed 15 participants through 3 prep sessions, an 8-hour guided journey on 25 mg of psilocybin, and 3 integration sessions, tracking their symptoms along the way. In the end, the results were staggering.

  • 📉 All (15 of 15) had lower depression scores just 3 weeks after that single dose. (And many responded within the first week.)

  • 🤗 Most (12 of 15) still met the criteria for complete remission 12 weeks after the journey. (No increase in mania or suicidal ideation, either.)

  • 💊 About ⅔ (9 of 15) never had to restart other meds. (Everyone weaned off their psychiatric medications at least 2 weeks before the study began.)

It’s worth calling out that this study was non-randomized. In other words, there was no placebo group, and everyone received the same treatment. They knew they were getting it, too.

But that doesn’t mean everyone had the same experience. In fact, the researchers noticed that people who had a more intense psychedelic experience tended to get a stronger clinical benefit. And conversely, without the trip there wasn’t much healing.

Guess the rollercoaster isn’t all bad. We’ll still take the 8-hour ride over the lifelong Tower of Terror, please. 🫠

AFTERGLOW
Omg it's happening.

You’ve got mail, FDA

Be still, my beating heart. (Seriously though, is this adrenaline, or did I just take a high-dose heart opener?) After devoting 30+ years to clinical research into the potential of MDMA-assisted therapy for PTSD, MAPS Public Benefit Corp has finally submitted its New Drug Application (NDA) to the FDA.

Cyclists, this is major—not just for MAPS and the roughly 13 million Americans suffering from PTSD, who’d appreciate a new treatment option that actually works. It’s also a pivotal milestone for the psychedelic industry at large. With this filing, MDMA becomes the first psychedelic therapy ever to be submitted for FDA approval.

So now what? Does this mean Rick Doblin can realize his dream of running MDMA-infused tap water into every home in America? Well, not exactly. (Never say never.) From here, it’ll take another 6 to 10 months for the FDA to make a decision. MAPS is hoping the Breakthrough Therapy Designation they snagged in 2017, combined with the extraordinary results from two Phase 3 clinical trials, will speed things along, but you never really know with government agencies. If all goes well, the first patients may have their hearts cracked open—with a doctor’s prescription—by the end of 2024.

Psychological defense bill

When soldiers are injured in combat—whether physically or psychologically—they should have access to the best available rehabilitation treatment. I mean, that’s the least the military can do, right? Fortunately, lawmakers from both sides of the aisle agree. This week, the House and Senate reached a deal to ensure active duty military service members get to participate in psychedelic clinical trials for PTSD and traumatic brain injury (TBI).

The decision came out of negotiations around the 2024 National Defense Authorization Act (NDAA), a massive, annual defense bill that covers all the training, equipment, and resources America’s forces might need to carry out their missions. The approved psychedelics provisions would require the Department of Defense (DOD) to set up a process to funnel service members into trials for psilocybin, MDMA, ibogaine, 5-MeO-DMT, and other “qualified plant-based alternative therapies.”

With $10 million in funding and a long list of eligible (and eager) research partners, the DOD would really have no excuse not to make it happen. Now, the renegotiated bill goes back to the House and Senate for final passage before heading to the President. Knock on wood, but at this point, the only way this goes sideways is if our elected officials are the ones with brain damage.

CYCLISTS’ PICKS
UNTIL NEXT TIME

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ONE CYCLIST’S REVIEW
Feeling euphoric

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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.

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