Australian Regulator Eyes Psychedelics

What’s Happening

The Therapeutic Goods Administration (TGA), Australia’s medical and drug regulator, is considering rescheduling MDMA and Psilocybin, the TGA is taking submissions from the public until September 28th. The review comes after Mind Medicine Australia, a not for profit, submitted an application to allow Australians with PTSD to undergo MDMA assisted therapy and those with depression to undergo psilocybin assisted therapy. 

Not so fast: The proposal doesn’t have the support of the medical establishment, both the Australian and New Zealand College of Psychiatrists say “the safety and effectiveness of these substances are not yet properly understood, and it was too early to be giving them to the public.”

What’s Next: If the TGA were to approve MDMA or psilocybin, Australia would be the first country to allow for broad access to these substances. What is much much more likely is the start of a compassionate use program, similar to the FDA’s Expanded Access program or Health Canada’s Section 56 exemption. 

Esketamine Faces Second Rejection in the UK

Spravato, Janssen’s ketamine derived nasal spray for treating depression, has been rejected for the second time by the NICE, the UK’s healthcare watchdog. The rejection came for two interrelated reasons:

Efficacy: Although Spravato has been approved by the FDA in the United States, experts are still undecided whether the treatment provides better outcomes than traditional antidepressants. NICE said they can’t approve “because it doesn’t know if improvements in depression symptoms continue after treatment stops.”

Cost: A single course of treatment with Spravato would cost £10,000. The costs of repeating a course of treatment are unknown, and the course of therapy requires monitoring after use, which requires special clinics, another unknown cost. 

Alternative Routes: Janssen is quoted as saying they’re confident another “route could be found for esketamine nasal spray to be made available for eligible patients.” A second consultation has now been launched, which is open until September 25th. 

Psyc Firms Announce New Leadership

A number of psychedelic companies announced new leadership last week, here’s a roundup: 

Cybin Corp has appointed Doug Drysdale as Chief Executive Officer. Drysdale is the former head of M&A for Activis Group (now a part of Allergen), where he led 15 acquisitions and helped raise $3 billion. Cybin Corp. has raised $10 million to date. 

Novamind Ventures Inc. announced the appointment of Dr. Reid Robinson as Chief Medical Officer. Dr. Robinson is the co-founder of Cedear Psychiatry and Cedar Clinical Research, organizations which Novamind acquired in 2019. Dr. Robison serves as the Coordinating Investigator for the MAPS’ phase II trial investigating MDMA and eating disorders, he previously led the Utah site for clinical trials of Spravato. 

New Wave Holdings Corp. (CSE: SPOR) has added Dr. Wade Davis, Ph. D. to it’s Psychedelic Research Advisory Board. Per the release, Wade Davis is a writer, photographer, and filmmaker, who was Explorer-in-Residence at the National Geographic Society from 2000 to 2013, he is currently Professor of Anthropology and the BC Leadership Chair in Cultures and Ecosystems at Risk at the University of British Columbia.

Microdosing on the Rise During Pandemic 

A new study has found that 1 in 5 young people in the UK has microdosed through the pandemic. 

What they’re dosing:

  • 51% of respondents reported microdosing prescription drugs 
  • Cannabis was a popular choice with 35% having tried it
  • 30% had microdosed GHB
  • Psychedelics, surprisingly, ranked at the bottom with 20% saying they tried psilocybin and 19% having tried LSD. 

Why they’re dosing: 

  • 25% reported that they microdosed to help with mental health issues
  • 16% said they did it to ‘cope with the pandemic’
  • 13% to deal with the financial issues
  • 13% tried microdosing to perform better at work and increase creativity. 

Zoom Out… The popularity of microdosing drugs makes it clear that there is a growing desire, especially among young people, to deal with their mental health issues with alternatives to pharmaceuticals. 

What Else We’re Watching

Psychedelic Therapy Draws Veterans to Jungle Retreats: The New York Times profiles veterans  seeking unregulated ayahuasca treatments for their mental health struggles. 

Champignon to Begin Offering Esketamine Treatment: Champ (CSE:SHRM) will offer the treatment for adults with major depressive disorder at their Canadian Rapid Treatment Centre of Excellence, located in the Greater Toronto Area. 

What to Do When Your Mental Health Professional is Opposed to Cannabis or Psychedelics: High Times has a guide for dealing with this tricky situation. 

Ehave Announced Psychedelic Retreat Plans: Ehave (OTC Pink: EHVVF) will offer the retreats through a network of affiliated providers. 

Cancer Patients’ Beautiful Experience: Inverse profiles cancer patients who have turned to psilocybin to deal with the mental toll. 

Special Forces Veterans Find Hope in Psychedelic Therapy for Treating PTSD and Traumatic Brain Injury: Veterans Exploring Treatment Solutions, Inc. (VETS) is supporting a Stanford study treating veterans with ibogaine.