đŸ«  This Week in Psychedelics

[5-min read] FDA accepts PharmaTher’s NDA for KETARX.

Welcome to Tricycle Day. Think of our newsletter like microdosing. It only works if you’re consistent and intentional. So open every issue and follow through by clicking some links! 👆

Here’s what we got this week.

  • SSRIs amplify DMT 🔊

  • $15 million for military research đŸȘ–

  • Coming soon: a ketamine patch đŸ©č

  • Your psychedelic biz launch plan 🚀

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Set & Setting

The top stories in psychedelic research, policy, and business

RESEARCH

DMT and SSRIs pack a 1-2 punch for depression

Let’s talk about synergy.

Bill Lumbergh

Ummm yeah, if you could go ahead and keep the corporate jargon out of my inbox, that’d be great.

No, not that vapid, powerpoint deck kind of synergy. In pharmacology (or drug science), "synergy" is the enhanced effect you get when two or more substances are used together, compared to when they’re used individually. In other words, when the combo is greater than the sum of its parts.

This week, researchers surprised everyone, even themselves, by finding an unlikely duo that’s bringing the synergistic heat
 DMT and SSRIs.Â đŸ”„

Just like penicillin and the smallpox vaccine, this antidepressant cocktail was discovered by accident. Here’s how.

  • 🧑‍🔬 Small Pharma is working on a version of DMT to treat major depression.

  • 💊 They just ran a small Phase 1b study where participants took their drug, SPL026, either alongside traditional antidepressants (SSRIs) or by itself.

  • đŸ„ Really, they just wanted to rule out any safety concerns. Because tapering off SSRIs can be challenging, and most people who could benefit from their drug are on ‘em.

  • 🙌 But the group who took SSRIs with SPL026 didn’t just avoid scary side effects. They had the best outcomes of the study. 100% of them responded to treatment, and 92% got to remission (vs 80% and 20%, respectively, for the non-SSRI group.)

In other words, SSRIs may actually make DMT more effective at treating major depression.

So just this once, we’ll allow your business buzzword. Just don’t ask us to “take this offline,” okay? We won’t be circling back.

MICRODOSES

đŸ€«Â Quiet quitting: A study has linked employees’ psilocybin use to working fewer overtime hours.

🐁 Self-actualized rodents: Microdosing increases resilience to stress and reduces compulsive behaviors in rats.

đŸ§‘â€âš•ïž Stay open minded: Psychiatrists have become much more optimistic about psychedelics over the last several years.

đŸ€šÂ That was unexpected: MDMA increases feelings of social connection
 and so does meth.

đŸŒ§ïž Not all sunshine and rainbows: Respected psychedelic researchers took an honest look at long-term negative responses to psychedelics.

POLICY

House clears $15 million for military psychedelic research

It’s a good week for the military, and a good week for ‘Murica. đŸ‡ș🇾

Why? Because the US House of Representatives just approved two pro-psychedelic amendments to the Defense Appropriations Act, a bill that governs how the Department of Defense (DoD) will spend its 2024 budget.

Between the two measures, here’s what the House has cleared.

  • 💾 The DoD would spend $15 million on “psychedelic medical clinical trials”

  • đŸȘ– The research would focus on active-duty service members with PTSD or traumatic brain injury (TBI)

  • 📝 The Defense Health Agency would report their findings back to Congress

Championing the effort are Reps Dan Crenshaw and Morgan Luttrell, two Republicans and ex-Navy SEALs from Texas, who’ve spoken out publicly on their own healing experiences with psychedelics. (Catch a clip from Crenshaw’s passionate floor speech. 👀)

But there are still some lingering voices of opposition. Like one Congresswoman, who says sure, veterans are fine, but serving plant medicine to active-duty military? That’s where things could get dicey with logistics and clearance.

I mean, what’s the worst that could happen? Our soldiers accidentally rediscover their interconnection with all other human beings, lay down their weapons, and hug it out?

Oh wait, yeah. I guess that would be a *ahem* logistical challenge.

I choose violence.

Ah, much better. 😅

MICRODOSES

🏡 Home grown: The Massachusetts group campaigning to put psychedelic legalization on the state’s 2024 ballot has chosen a version of the initiative that would allow home cultivation.

🩞 The other Portland: The city council of Portland, Maine has passed a resolution to deprioritize enforcement of laws related to psychedelic plants and fungi.

🧟 Back from the dead: Lawmakers in Pennsylvania are reviving a rejected bill that would support research into psilocybin for mental health treatments.

đŸ‡§đŸ‡·Â Out of the jungle: 50% of Brazilians say they’d consider a psychedelic medical treatment if recommended by their doctor.

BUSINESS

Ketamine delivery is evolving

Red alert: We have a ketamine shortage. 🚹 

It’s true. Ketamine has been on the FDA’s official drug shortage list since 2018. And Canada added it to its list in February of this year.

Maybe that’s because it’s still the only legal psychedelic medicine, and everyone and their mom is struggling with their mental health right now. Idk, just a hunch.

Struggle bus

Beep, beep. This is your stop! 🚌

Actually, it’s a bit more complicated than that. Ketamine is technically only approved as an anesthetic, so it’s normally used to put people under for surgery. Ketamine clinics—where therapists dish out smaller doses for depression and anxiety—are a more recent trend.

Now, a company called PharmaTher is stepping in to backfill the growing demand. This week, their FDA application was accepted. With that nod, they’re expecting approval to launch under the brand name KETARX by April 29, 2024.

But here’s where things get interesting. PharmaTher is taking plain ol’ ketamine and delivering it through a new method. Instead of syringes, IVs, or lozenges, they’re packing it into a “hydrogel microneedle patch.”

After testing the patch extensively, PharmaTher claims it:

  • Offers better efficacy (therapeutic results), compared to other administration methods

  • Improves compliance (whether patients actually use it as prescribed)

  • Is pain-free, tamper-proof, and good for up to 30 days

So if you catch us on the street rocking a weird band-aid, just know we didn’t get a boo-boo. đŸ€•

MICRODOSES

đŸ‘Ÿ Decoding psychedelics: BrainFutures has released a user’s guide to medical billing codes for psychedelic-assisted therapy.

🚔 Po-po shut us down: Soul Tribes, a psychedelic church in Detroit, has been raided by police. Meanwhile, the city of Vancouver is trying to revoke business licenses from local mushroom dispensaries.

đŸ›Œ Roll on: Tactogen has won the first ever US patent grant for novel MDMA derivatives.

🌿 Mo’ money, mo’ plants: Filament Health plans to raise $2 million in a private investment round led by Negev Capital.

🧊 Bufo on ice: GH Research’s investigational new drug (IND) application for a proprietary form of inhalable 5-MeO-DMT has been put on hold. The FDA ruled it had “insufficient information to assess risks to human subjects.”

Trip Reports

Hot takes from around the web

Cyclists' Picks

Our favorite opportunities for mind expansion

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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.

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