Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed
FDA Issues Warning Letter for Ketamine
The FDA has issued a warning letter regarding the use of ketamine outside of FDA-approved conditions. This notice seems to be in response to the growing use of ketamine for the treatment of mental health conditions.
With the increased and un-regulated use of ketamine to treat mental health conditions (outside of ketamine’s original FDA approval) there have been growing concerns of misuse, abuse, and other potential dangers — the likely motivation behind this letter.
Cybin Shareholders Approve Acquisition of Small Pharma
Cybin shareholders have approved the acquisition of Small Pharma with 99.4% of the vote.
The all-share transaction will have Cybin acquire Small Pharma’s Phase 2 DMT trial for depression, a study that posted very impressive results earlier this year. Along with Cybin’s existing DMT CYB-004 program and its CYB-003 trial for depression, this acquisition boosts Cybin further up the ladder of top-tier psychedelic medicine firms. Small Pharma shareholders will receive 0.2409 common shares of Cybin.
New Study Shows Microdoses Reduce Compulsive Behavior (in rats)
Repeated low doses of psilocybin increase resilience to stress, lower compulsive actions, and strengthen cortical connections to the paraventricular thalamic nucleus in rats
Published in Molecular Psychiatry,
this new study gives some observational data to support people’s anecdotal reports on the benefits of microdosing.
Filament Health Receives Approval of Phase 2 Trial
Filament Health announced Health Canada approval for a phase 2 clinical trial at the University of British Columbia (UBC). The trial will study the effects of PEX010, Filament’s botanical psilocybin drug candidate, for the treatment of opioid use disorder (OUD).
“Opioid use disorder is one of the most challenging public health issues and a major contributor to the escalating overdose crisis in Canada,” said Dr. Christian Schütz, Professor of Psychiatry at UBC and Principal Investigator for the trial. “This trial will assess the safety and feasibility of delivering psilocybin in the treatment of OUD, and evaluate potential changes in participants’ opioid use. We are grateful to Filament Health for funding and facilitating this trial.”
Mydecine Begins Trading on the European AQSE Exchange
Mydecine Innovations Group has been out of the news for a while, a stretch of radio silence after months of interval drama that had the company apparently teetering on the edge of closing shop. In an apparent sign of life, the company’s share began trading on the European AQSE growth market — although the volume has been nearly non-existent.
