Issue 57 / Wednesday June 8, 2022
FDA approval of MDMA for PTSD and psilocybin for depression is anticipated within the next 24 months, according to a letter from the Department of Health and Human Services.
The department is also considering starting a federal task force dedicated to addressing complex issues surrounding psychedelics such as harm reduction and safety.
“Too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis,” the letter explains.
After receiving three ketamine therapy sessions in Awakn’s Phase 2 trial, patients with alcohol use disorder achieved an increase in abstinence from around 2% to 86%. This means they abstained from alcohol for an average of 162 of the 180 days following the treatment 👏
The results were so encouraging that the UK government granted the company CA$2.5M to fund Phase 3 of the trial.
The grant covers two-thirds of Awakn’s costs and marks the first time that a Phase 3 psychedelics trial has received government funding.
With 280 patients across 7 sites in the UK, it will be the largest ketamine-assisted therapy trial to date!
A new government-funded study will see if psilocybin can ease depression without producing a psychedelic effect – and no, we aren’t talking about microdosing…
At Toronto’s Centre for Addiction and Mental Health, adults with treatment-resistant depression will receive a full dose of psilocybin + 12 hours of therapy.
What makes this study unique is that some patients will also receive a serotonin blocker, which will block the psychedelic or hallucinogenic effects of the psilocybin.
If benefits can be delivered while avoiding the trip, this could open up psilocybin therapy to those who aren’t typically candidates for the treatment, as well as people who don’t want to hallucinate.
Learn how you can participate in the study here 👇
Compass Pathways (CMPS) initiated a Phase 2 psilocybin therapy trial for anorexia. It will be conducted on 60 subjects across 4 research sites.
Small Pharma (DMT) was granted a patent for its formulation of injectable DMT, marking its first US patent and ninth patent to date.
MindBio Therapeutics of Blackhawk Growth (BLR) received NZ$1.44M from the New Zealand government to study LSD microdosing for depression.
Braxia Scientific (BRAX) shared year-end financial reuslts includine $8.6M in cash and $1.49M in revenue, up 47.5% from the previous year. The company’s net loss was $12.1M compared to $88.8M the year prior.
In January, the DEA proposed to ban 5 psychedelic drugs (4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT) by classifying them as Schedule I substances.
After receiving significant pushback, the DEA has withdrawn the proposal.
Instead, the agency is requesting for the Department of Health and Human Services to conduct scientific and medical evaluations of the drugs to guide scheduling recommendations.
After sexual misconduct allegations arose from one of MAPS’ MDMA trials, Health Canada promised to review all upcoming MDMA trials that were previously approved.
Following the review, MAPS’ MDMA trial in Toronto has been suspended due to concern of patient safety.
Some issued noted include “failure to conduct the study according to the approved protocol, problems with quality control and staff training, and a lack of informed written consent from participants.”
However, MAPS’ MDMA trial in Montreal is allowed to proceed given that some “corrective and preventive” changes are made