Breakthrough therapy designation for atai/Beckley 5-MeO-DMT drug; both ketamine and active placebo improve depression symptoms; and ketamine company to receive priority FDA review
Plus: New study questionnaire probes ibogaine experiences and Cannabis company lawsuit could have implications for psychedelics
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.
Breakthrough therapy designation for atai/Beckley 5-MeO-DMT drug
In another sign that the federal government is looking to move more quickly to approve and test new drugs, last Thursday, psychedelic pharmaceutical company atai Life Sciences and UK-based biotech company Beckley Psytech announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for BPL-003, a synthetic nasal form of 5-MeO-DMT, for adults with treatment-resistant depression. The FDA designates Breakthrough Therapy status to “expedite the development and review of drugs for serious or life-threatening conditions.” Beckley developed BPL-003 and in January, it announced promising preliminary results from a Phase 2 study using it to treat alcohol use disorder; in June, Beckley and atai announced they would be merging.
On X, atai co-founder and ex-CEO Florian Brand said that the atai and Beckley teams would be releasing more data from an open-label BPL-003 study later this month, and that atai has recently raised some $150 million in equity financing. In the companies’ release, Beckley CEO and co-founder Cosmo Feilding Mellen said that the breakthrough therapy designation “will help to ensure the pivotal Phase 3 clinical program will be as expedited and efficient as possible, guided by the FDA.”
Both ketamine and active placebo improve depression symptoms
A new study published in JAMA Psychiatry on Wednesday found that there was no statistically significant difference in depression scores between participants receiving intravenous ketamine versus those receiving intravenous midazolam, a benzodiazepine used as an anesthetic. The study included 62 participants who were clinically diagnosed with moderate to severe depression. Participants went to the hospital twice a week for up to eight 40-minute sessions, where they received either ketamine or midazolam.
After those eight sessions, both groups had lower depression scores compared to their intake baseline, but there was no significant difference between those who had received ketamine and those who received midazolam.
The study authors write that these results “underscore the need for a cautious interpretation of earlier, less rigorously controlled research” on the potential of ketamine to treat depression. Much of that previous research used saline injections as a placebo control group for ketamine, the authors write, which could mean that participants knew whether or not they’d received ketamine and that therefore some of their resulting decreases in depression could have been due to expectancy effects.
But this study’s results also raise questions about the role of unblinding and expectations. When researchers who did not know which drug participants received were asked to guess at various intervals throughout the study, they did so with an extraordinarily high level of accuracy — 90% in some cases. Participants also generally guessed which drug they received at a higher-than-chance rate: 78.1% who received ketamine guessed correctly after the first and second sessions, and that numbers climbed to 85% at the 6-month follow-up.
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Ketamine company to receive priority FDA review
Last Thursday, the U.S. Food and Drug Administration announced nine companies whose drugs would receive a priority review from the agency. Under a new FDA initiative called the Commissioner’s National Priority Voucher pilot program, voucher recipients will receive an expedited review and a decision on approval within 1 to 2 months.
Among those voucher recipients is a company called Phlow, which will establish a ketamine supply chain in the U.S. Currently, much of the world’s ketamine is produced in China and India, and diversion to the illegal market has led to worldwide ketamine shortages over the last 10 years. In a press release, Phlow says developing a more robust U.S. ketamine manufacturing pipeline will ensure “high-quality, affordable, and sustainable access to patients and health systems.” Over the summer, the company announced it had raised $37 million in Series C funding to support its work sourcing active pharmaceutical ingredients and “helping restore America’s pharmaceutical sovereignty.”
The FDA has awarded this voucher to Phlow for developing ketamine for use as a general anesthetic, but the drug is also widely used off-label in mental health treatments, and some in psychedelics-adjacent circles are cheering the decision. PharmaTher, a ketamine and psychedelics company, published a press release stating that the FDA’s decision “point[s] to sustained momentum for ketamine” and “strengthens the rationale for pharmaceutical partners to engage in the development and commercialization of novel ketamine products for new indications.”
New study questionnaire probes ibogaine experiences
People who have tried ibogaine often say it’s a unique experience, different from the effects of psilocybin and other classic psychedelics like LSD or DMT. Typically, psychedelics studies use standard measures like the Mystical Experience Questionnaire to capture people’s subjective experiences, but according to the authors of a new paper published in PLoS ONE, some researchers believe that there may be a “misalignment between the items measured by these instruments and the ibogaine experience” that calls for the development of an ibogaine-specific measure. The paper’s authors set out to do just that by creating the Ibogaine Experience Scale (IES).
To develop the scale, the researchers started by reviewing previous studies that included interviews with ibogaine clients and developed a conceptual framework based on the themes that arose. Those included categories of effect types such as visual, auditory, and cognitive, as well as subcategories about specific experiences, like empathy, ego dissolution, or spiritual experiences. The study authors then tested a preliminary version of the IES with 499 people who were clients at the ibogaine treatment center Ambio Life Sciences, located in Tijuana, Mexico, and refined the initial questionnaire from 144 questions to 70. The final version includes questions that attempt to capture the often dream-like experience of ibogaine: Did you see visions of the origin of life (e.g., evolution of the universe, Earth, and life)? Did you see visions of futuristic technology? Did you see scenes that repeated themselves?
The authors recommend that future research investigate whether the questionnaire adequately captures the ibogaine experience across other samples, especially ones more diverse than theirs. (Of the roughly 500 participants included, 404 were men, and 460 were visiting from the U.S.) A more diverse group, they write, could reveal even more themes to include in the questionnaire.
Cannabis company lawsuit could have implications for psychedelics
Last Friday, a New Mexico medical marijuana company doing business as Ultra Health filed a brief in U.S. Tax Court that could have implications for psychedelics businesses. The company, along with all other cannabis and psychedelics companies, is subject to a tax policy known as Section 280E, which prevents businesses “trafficking in controlled substances” from deducting business expenses on their taxes. Ultra Health argues that Section 280E should not have applied to their company during certain tax years due to federal policy barring prosecutors from enforcing the federal Controlled Substances Act against state-compliant medical marijuana businesses during that time, reports Law360’s Sam Reisman. Furthermore, the company argues that they are entitled to refunds for overpayment of taxes during those years.
Like cannabis, classic psychedelics like psilocybin and LSD are still classified as the most restricted, Schedule I drugs, and state-legal psilocybin businesses in states like Oregon and Colorado have also had to navigate Section 280E. In their brief, Ultra Health writes that the policy, enacted in the 1980s, was intended to find ways to penalize drug dealers, and is now outdated. If the company’s claims move forward, the case could have huge implications for what taxes cannabis and psychedelics businesses are liable for in the future.
Doug Drysdale, former CEO of psilocybin company Cybin, is now a corporate advisor at BetterLife, according to a BetterLife press release. BetterLife is developing BETR-001, a patented form of 2-bromo-LSD, a chemical cousin of LSD that does not produce hallucinations; the company is developing its use in treating cluster headache and migraines.
The psychedelic renaissance has reached Puerto Rico, reports Lucid News.
A small group of researchers believe that some of magic mushrooms’ effects are not due to psilocybin alone, but are instead the result of an “entourage effect” of the dozens of other compounds found within, reports Chemical & Engineering News.
In recent months, Toronto’s psilocybin mushroom shops have seen a string of attacks, including a shooting, arson attempts, and even cars crashing into storefronts. For DoubleBlind, Mattha Busby reports that the “psychedelic turf wars have officially begun.”
The BBC profiles Erowid, the “drug website that transformed psychedelic research.”
In Filter, Jack Gorsline reports on the latest volleys in an Oregon lawsuit seeking accommodations for disabled and terminally ill patients to receive psilocybin sessions at home: while the state argues that the lawsuit should be dismissed, the plaintiffs argue the state is just attempting to sidestep their concerns.
On Tuesday, U.S. Customs and Border Protection announced it had seized more than 160 pounds of ketamine at the Hartsfield–Jackson Atlanta International Airport earlier this month. On two different days, plastic bags of ketamine were intercepted in luggage arriving from Paris.
After Chuck Lovett was sexually abused by a Catholic priest in his childhood, the diocese gave him $10,000 to spend on therapy — and he used part of it to pay for psilocybin sessions. Willamette Week tells Lovett’s story; the diocese told the publication that they made a “one-time exception” when they approved Lovett to spend his funds on psilocybin.
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