FDA expands Spravato approval, and the Future of RFK Jr. and federal agencies' approach to psychedelics in limbo
Plus: Colorado synthetic psilocybin bill passes house and Massachusetts introduces flurry of psychedelics legislation; Living systematic reviews; and psychedelic exceptionalism
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 expands Spravato approval
On Tuesday, pharmaceutical giant Johnson & Johnson announced that its nasal esketamine medication Spravato received approval from the Food and Drug Administration to use the medication as a “monotherapy” — a standalone treatment — for depression. The FDA first approved the drug in 2019 but required patients also take an antidepressant alongside esketamine treatment.
Esketamine is a component of generic ketamine, which is a 50/50 mixture of the enantiomer molecules esketamine and arketamine. (Enantiomers are pairs of molecules that are mirror images of one another.) Pharmaceutical companies cannot patent generic ketamine for depression, but Janssen, a subsidiary of Johnson & Johnson, patented esketamine, which it named Spravato. The cost of the two drugs differ significantly. Per treatment session, the cost of generic ketamine is less than a few dollars, whereas Spravato costs $600 or $900 per session, depending on dosage. Those figures do not include the cost of associated medical services.
Future of RFK Jr. and federal agencies’ approach to science (and psychedelics) in limbo
This week, as President Trump took office, his team appointed endocrinologist Dorothy Fink as interim secretary of the Department of Health and Human Services. Trump’s nominee for the role, Robert F. Kennedy Jr., faces bipartisan pushback over a variety of issues including his history of promoting conspiracy theories about COVID, his anti-vaccine activism, and his voting record on abortion. Former Vice President Mike Pence’s organization Advancing American Freedom announced Wednesday that it would be “launching a six-figure ad campaign opposing RFK Jr.’s nomination to lead HHS.” Hours later, the White House announced Kennedy’s nomination hearings would be held next Wednesday.
Kennedy has vowed, if confirmed, to end what he called FDA “suppression” of psychedelics.
Meanwhile, the Trump administration has also ordered federal health agencies to pause all external communications, which includes social media posts, website updates, and health advisories through February 1, as well as the cancellation of grant review panels. These restrictions apply to a range of federal agencies including the U.S. Food and Drug Administration and the National Institutes of Health, which has committed more than $1 million to psychedelics-related research for the 2025 fiscal year. Trump administration policies could also affect funding for new psychedelics research in the U.S., as well as researchers’ jobs, as the new administration has also issued a government-wide hiring freeze.
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The State of Psychedelics: Colorado synthetic psilocybin bill passes house, and Massachusetts introduces flurry of psychedelics legislation
Last week, we reported that Colorado’s Health and Human Services Committee advanced HB 1063, a bill that would make it state-legal to prescribe and use a certain form of synthetic psilocybin, should it be approved by the U.S. Food and Drug Administration. On Wednesday, the house voted to pass the bill, which now heads to the State Senate.
The bill specifically refers to “crystalline polymorph psilocybin,” which appears to be aimed at preferentially legalizing COMP360,a psilocybin formulation developed by the company Compass Pathways. Last week, senators in Virginia passed a similar bill that would state-legalize only COMP360, should the FDA approve it. The Microdose reached out to the sponsors of both bills and to Compass Pathways but did not receive a reply before publication.
In Massachusetts, advocates have moved on from their loss in November’s election, in which the state’s voters rejected Question 4, a ballot initiative that would have created a state-regulated psychedelics program and removed prosecution for growing, possessing, and using small amounts of “natural” psychedelics, including psilocybin and DMT.
In a press release, local activists who worked on the Question 4 campaign said “they met with lawmakers and grassroots allies to encourage a broad range of legislation to be filed and to promote bottom-up, decentralized leadership.” This month, legislators have proposed ten new psychedelics-related bills, including those that create a task force to study the drugs, commit funds and other resources for psychedelic research, and establish a state psilocybin program similar to New York’s, where adults could take a health screening and course to receive a permit to buy and use psilocybin. There are also three separate bills (HD4017, SD1624, and HD4196) proposing pilot programs for psilocybin therapy treatment centers.
Living systematic reviews
Earlier this month, a group of researchers announced the launch of a new initiative called the Synthesis of Psychedelic Research Studies (SPYRES). To get a summary of existing research on a particular topic like psychedelics, scientists look to so-called review studies that analyze the findings of multiple existing studies. “Traditional systematic reviews quickly become outdated, failing to capture the most recent developments,” the SPYRES researchers wrote in commentary published in Nature Mental Health introducing the endeavor.
Under that traditional publication model, review studies are published one at a time, and because it can take months or even years to publish papers, even “new” papers may not contain the newest data. The SPYRES model, the authors write, will instead create a series of meta-analyses that are regularly updated as “living systematic reviews,” where new research results are integrated into a publicly available dashboard. The first phase of the study will investigate the safety and efficacy of MDMA in treating PTSD and of psilocybin in treating depressive symptoms; the second will look at the efficacy of using psilocybin and LSD in the treatment of anxiety symptoms.
“The research examining psychedelic therapy is at a pivotal juncture,” the researchers write. “Although the therapeutic potential of these compounds is promising, the need for robust evidence synthesis is equally crucial.”
Psychedelic exceptionalism
The first issue of this year’s American Journal of Bioethics is dedicated to psychedelics research, delving into everything from the use of “supportive touch” in psychedelic-assisted therapy to what federal psychedelics policy could look like this year. A theme that runs throughout the issue is what the authors call “psychedelic exceptionalism”: Are these substances so unique that they merit special treatment in how they’re regulated and studied? For instance, it’s “unusual” in the pharmaceutical world for researchers to be encouraged to try the drugs they’re studying, write Harvard legal scholars Mason Marks and Glenn Cohen, and it’s unclear whether this could “potentially make researchers advocates for psychedelic use, which raises concerns regarding potential expectation bias in clinical trials.”
Veterans Affairs researchers Katrina DeBonis and Walter Dunn and University of California Los Angeles’s Thomas Strouse further explore this thread in a commentary, arguing for maintaining equipoise — genuine uncertainty or lack of bias about whether a treatment will be effective. They wrote, “Research teams would benefit from balanced composition in which clinicians and researchers without personal experience and with negative psychedelic experiences are invited to contribute their perspectives to study design and serve as facilitators.”
The issue also explores different viewpoints about how to apply ethical and evidentiary standards to psychedelics. In another article in the issue, researchers argue that though some researchers or advocates believe psychedelics’ unique properties mean they should be treated differently from traditional medications, the substances should still be subject to the same ethical standards used in other clinical studies. But in a response by Oxford neuroethicist Edward Jacobs, what some may see as a call for psychedelic exceptionalism is really an appeal for new evaluation methods. “Where Cheung et al see calls for different rules for psychedelics, I tend to see appeals for different tools,” he writes. “What I see are arguments that different approaches may be needed to meet the same ethical requirements we hold across medicine.”
The news show CBS Mornings explores the intersection of Jewish faith and psychedelics.
Psychedelic Alpha published a detailed analysis of Lykos Therapeutics’ patent applications for what it’s claiming as the company’s MDMA formulations. As PA’s Noah Smith puts it: “MAPS’ historic ‘anti-patent strategy’ means Lykos was late to the game in filing patent applications on MDMA, leading it to pursue an arguably shaky strategy: claiming specific particle sizes.”
University College London researchers are launching a new study investigating the use of DMT in treating alcohol use disorder, reports The Guardian.
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