FDA will fast-track Lykos’s application for MDMA-assisted therapy for PTSD; New Illinois bill; and Canada’s first psilocybin clinical trial
Plus: Psychedelics as “synthetic surprise,” and new legal filing prods DEA for a ruling on psilocybin
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
FDA will fast-track Lykos’s new drug application for MDMA-assisted therapy for PTSD
In late December 2023, Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced they’d submitted a New Drug Application to the U.S. Food and Drug Administration for MDMA-assisted therapy as a treatment for PTSD. Last Friday, Lykos announced that the FDA had accepted the application and will expedite its review. The FDA will make its decision by August 11, 2024.
The State of Psychedelics: New Illinois bill
This legislative session has seen multiple states — California, Hawaii, Maine, Missouri, and New Jersey — proposing state-regulated psychedelic access programs similar to those that were enacted via ballot measures in Oregon and Colorado. This is a departure from legislative sessions in 2022 and 2023, when state psychedelics bills focused more on decriminalization, forming “workgroups” to investigate psychedelics, and providing funding for psychedelics research.
Illinois is the latest state to jump in. Last Friday, State Senator Rachel Ventura (D) introduced Senate Bill 3695, which would create a state-regulated psilocybin program allowing licensed facilitators to provide psilocybin services, and licensed businesses to manufacture and test psilocybin mushrooms. Called the Compassionate Use and Research of Entheogens (CURE) Act, the bill would give the state two years to develop rules and regulations to implement its program. La Shawn Ford (D) also introduced HB1, SB 3695’s companion bill, in the state House. Ford introduced the CURE Act in last year’s legislative session as well, but it languished in committee.
Want the latest psychedelics news? Subscribe! (It’s free!)
Canada’s first psilocybin clinical trial
Researchers at the University of Toronto and McMaster University headed up Canada’s first completed psilocybin clinical trial, which used the drug to treat 30 people diagnosed with treatment-resistant depression associated with major depressive disorder or bipolar type II disorder. Over three therapy sessions, participants received psilocybin at least once, with some participants receiving two or even three doses.
Their results, recently published in the journal Clinical Advances, echo those of other recent psilocybin clinical trials: participants showed greater improvements in their depression symptoms after one session of psilocybin-assisted therapy compared to participants who did not. In addition, the researchers reported, "Repeated doses of psilocybin were associated with greater antidepressant effects.”
On X, lead author Joshua Rosenblat, a psychiatrist at the University of Toronto, wrote that the study was the result of one Canadian patient’s request to legally access psilocybin. Meanwhile, psychedelic advocates in Canada have been calling for the government to open up other avenues to patients seeking psilocybin-assisted therapy.
The study was funded by Canadian company Braxia Scientific and non-profits Brain and Cognition Discovery Foundation and Usona Institute.
Do psychedelics create “synthetic surprise”?
In an article recently published in Neuroscience and Biobehavioral Reviews, Berlin-based researchers Roberto De Filippo and Dietmar Schmitz posit an interesting new theory about psychedelics and consciousness: the drugs induce what the authors call “synthetic surprise.” If surprise is a mismatch between a brain’s predictions of the future and what actually happens, then perhaps the altered state psychedelics elicit is just a chemically-induced twist on surprise. Psychedelics work on 5-HT receptors, the activation of which, the authors posit, could be the source of this synthetic surprise.
If their theory holds, it could have major implications for the clinical use of psychedelics. “The potential antidepressant properties of these compounds may not be attributed primarily to a specific pharmacological action, but rather to the subject experience of encountering something profoundly novel,” the authors write, giving examples of other drugs that initially showed therapeutic promise but have fallen out of favor as their novelty has decreased, like benzodiazepines and barbiturates, opioids, and the anesthetic propofol. Of course, further research into the theory is necessary, the authors write, but putting forth the idea provides another avenue for understanding psychedelics’ potential mechanisms of action.
New legal filing prods DEA for a ruling on psilocybin
For years, physician Sunil Aggarwal of Seattle’s Advanced Integrative Medical Science Institute (AIMS) has been engaged in a series of lawsuits seeking access to psilocybin for patients in palliative care. This week, Aggarwal and his legal team filed a new brief in the U.S. Court of Appeals for the Ninth Circuit, calling on the court to reverse the U.S. Drug Enforcement Administration’s final decision in 2022, which denied Aggarwal’s request for access.
Over the years, Aggarwal’s legal team has tried other avenues to access the drug for his patients, such as requesting that the DEA reevaluate the existing evidence for classifying psilocybin as a highly restricted, Schedule I drug. Thus far, Aggarwal has not had success in those efforts either. In November 2023, Aggarwal’s team got their first encouraging sign: the Ninth Circuit ruled in favor of Aggarwal, saying that the DEA had failed to adequately explain its rejection of his psilocybin access request, but the court did not set a timeline for the DEA to make an alternate ruling. This most recent filing is an attempt to get the courts to take further action on the case sooner. “It is maddening it is taking so long, caused by the DEA slow walking this matter and the related but separate rescheduling matter,” Kathryn Tucker, one of Aggarwal’s lawyers, said in a written statement to The Microdose. Tucker says the DEA would need to file an answering brief by April 8.
Australia’s first psilocybin therapy clinic is charging $24,000 Australian dollars for treatment (roughly $15,500 USD), according to The Guardian — a steep price when researchers are still studying the drug’s effectiveness in treating depression.
Psychedelic Alpha published Part 1 of its recap of the Reagan-Udall Foundation’s two-day psychedelics conference about psychedelic study design. The Reagan-Udall Foundation is a non-profit created by Congress to advance the U.S. Food and Drug Administration’s work. During the conference, government and academic researchers discussed the role of expectation and blinding in study design and considerations for determining patients’ dosing regimens.
MAPS announced the organization’s Psychedelic Science conference will return to Denver in 2025.
What happens if you commit a crime while on psychedelics? Jules Evans reviews previous cases in Ecstatic Integration.
The University of Amsterdam is offering a two-week summer seminar on the global history of psychedelics, taught by scholars J. Christian Greer and Erik Davis.
You’re all caught up! Have a great long weekend. We’ll be back in your inbox next Friday with another issue of This Week in Psychedelics.
If you know anyone who might like the latest on psychedelics in their inbox, feel free to forward this to them, or click below.
Got tips? Email us at themicrodose@berkeley.edu.