The article News You Might Have Missed: Feb 6th, 2023 was originally published on Microdose.
Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed. It was a busy week with lots of news, have a look and see you next week for another update.
Australia Reschedules Psilocybin and MDMA for Therapeutic Use
Last week’s biggest news was Australia rescheduling psychedelics psilocybin and MDMA for therapeutic use.
Starting in July, the Therapeutic Goods Administration (TGA) will permit the prescribing of MDMA for the treatment of PTSD and psilocybin for treatment-resistant depression. These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients.
Seems the Australian government has decided to follow the evidence presented by academic research and advanced clinical trials using psilocybin for depression and MDMA for PTSD.
Origin Signs Letter of Intent to Acquire Safe Supply Streaming
The two companies announced a transaction to create the world’s first publicly-listed pharmaceutical and narcotics investment company, aimed at taking advantage of the rapidly growing safe supply narcotics sector.
“Safe supply will be the next shoe to drop in the decriminalization discussion. Without safe, lab-tested supply, we will continue to put many people at risk. At Safe Supply Streaming our aim is to ensure we are supporting a worthwhile social goal for all Canadians while ensuring a diversified portfolio of investment opportunities in a nascent sector for our shareholders.” Bill Panagiotakopoulos, CEO Safe Supply Streaming.
Apex Labs Granted Approval for At-Home Phase 2b Psilocybin Trial
Under-the-radar psychedelic firm Apex Labs has announced approval by Health Canada of a Phase 2b trial.
According to the company, this would be the world’s largest take-home psilocybin clinical trial to date. The trial will be a randomized, double-blind, placebo-controlled phase 2b study, looking at the efficacy, safety and tolerability of APEX-52.
APEX-52 is a microdose, orally administered synthetic psilocybin drug treating depression and anxiety among adults diagnosed with Post-Traumatic Stress Disorder (PTSD).
FDA Grants Pharmather Orphan Drug Designation for KETARX (Ketamine)
Pharmather continues to add to its niche yet increasingly impressive portfolio with another Orphan Drug designation by the FDA, this time for its KETARX (Ketamine) for the treatment of Rett Syndrome.
This is PharmaTher’s 5th FDA orphan drug designation for its KETARX compound:
- Treatment of Rett Syndrome
- Prevention of Ischemia-reperfusion injury from organ transplantation
- Treatment of Status Epilepticus
- Treatment of Amyotrophic Lateral Sclerosis
- Treatment of Complex Regional Pain Syndrome
Health Canada Approves Diamond Therapeutics’ Phase 2 Trial of Low-Dose Psilocybin
Diamond’s Phase 2 trial has been approved by Health Canada, a four-week, Phase 2 randomized, double-blind study in adult patients with Generalized Anxiety Disorder (with the potential for an additional four-week open-label extension. Patients will receive repeat low doses of psilocybin administered on a take-home basis.
This Phase 2 trial follows Diamond’s Phase 1 trial of fifty-six subjects that established a safe, tolerable dose range for the use of low, non-psychedelic doses of psilocybin.
Terran Biosciences Files Patent for Oral DMT and 5-MeO-DMT
Terran Biosciences is attempting to innovate the development of compounds like DMT and 5-MeO-DMT with oral delivery forms. The company has filed patent applications for novel compounds designed to be given as a single oral dose, avoiding first-pass metabolism, and releasing high levels of the original active molecule in the brain.
The PCT application “N,N-Dimethyltryptamine and Related Psychedelics and Uses Thereof” can be seen here and here.
Want to catch up on more industry news? Check out a previous edition of the News You Might Have Missed