Ketamine Gone Wild
On January 31, 2020, Secretary of Health and Human Services, Alex Azar, declared that all medical practitioners could issue prescriptions without in-person evaluation.
- Azar’s policy response was due to the public emergency presented last year by the COVID-19 pandemic.
- It was a shift from the Ryan Haight Act of 2008, which was enacted then to prevent the illegal distribution and dispensing of schedule II-V controlled substances via the Internet.
What Happened: The change gave practitioners, including a number of “psychedelic clinics” greater freedom to distribute ketamine without an in person consultation with a patient.
The Problem: The American Society of Ketamine Physicians, Psychotherapists and Practitioners (ASKP3) has grown concerned with how freely ketamine is being administered.
Solution: The Society announced their Standards of Practice in the Therapeutic Use of Subanesthetic Ketamine. With these new guidelines, the ASKP3 has provided guidelines to prioritize the safety of patients and protect research advances by certified ketamine practitioners.
Final Thought: While ketamine therapies have proven effective, there remain many unknowns. Importantly, as the ASKP3 says ketamine is “not a panacea” for all of life’s problems.
Training Psychedelic Therapists
TheraPsil, a Canadian non-profit, is launching a training program for healthcare practitioners to experience a mushroom trip. The aim: to better prepare providers to administer psychedelic assisted therapy.
Spencer Hawkswell, CEO of TheraPsil, says it’s “incredibly important” for patients that their therapist understands the psychedelic experience.
A step in the right direction.
The 10-week program, helmed by Dave Phillips, is being taught via a virtual classroom. His students, consisting of 20 experienced psychotherapists and nurses, have agreed to try psilocybin themselves. With this personal experience under their belt, they’ll be equipped to guide patients through a trip.
Phillips said “… Studies were showing with [psychedelics], etc. that we were getting, like 60-80% positive outcomes.”
A few bad apples…
With growing interest and awareness, demand for psilocybin-assisted therapy is expected to skyrocket. A former patient now warns of the danger of sexual abuse, and is demanding new safeguards.
- In 2015, Meaghan Buisson entered a clinical trial for the use of MDMA to treat PTSD. She alleges having been assaulted sexually by Psychiatrist Dr. Donna Dryer and psychotherapist Richard Yensen – a married couple trained by MAPS.
- Richard Ingrasci was permanently barred from practicing psychiatry in 1989 after patients came forward to allege he sexually abused them while they were on MDMA.
- Psychiatrist Francesco DiLeo of Maryland had been disciplined for similar violations in 1987.
Since Buisson’s experience, MAPS formalized a ‘Code of Ethics’ to make clear that practitioners must “avoid entering into dual relationships that are likely to lead to impaired professional judgment or exploitation.” However, they haven’t tightened policies regarding who can act as a therapist in clinical trials, and only 1 member of a team needs to be licensed for practice.
In December, the Federation of Associations for Counseling Therapists in British Columbia (FACTBC) submitted a formal application to Health Minister Adrian Dix, to call for urgent regulation in the profession.
Major Players Expand Their Patents Portfolio
Mindset Pharma (CSE: MSET) is betting big on the potential of DMT and its novel applications. They’ve now filed for a 6th provisional patent with the US Patent and Trademark Office.
- This new proprietary application covers a range of DMT and 5-MeO-DMT derivatives, their synthesis, composition, and therapeutic uses.
- Derivatives could reduce toxicity and metabolic liabilities, for a safer psychedelic experience.
- Mindset now possesses 6 distinct patent-pending compounds in development.
Mindset is not alone in this big push to diversify their psychedelic portfolio.
Tryp Therapeutics (CSE: TRYP) is also diligently aiming to differentiate their tailored range of psychedelic medications. They’ve just filed for a new provisional patent to improve the administration of medicines with the following methods:
- Measuring the response to psychedelic therapeutics to further support a controlled experience.
- Manufacture the active pharmaceutical ingredient and novel formulations.
- Enhance the safety profile of treatments.
- Reduce risk of abuse and addiction.
With these new methods and patented formulations, Jim Gilligan, PhD, President and Chief Science Officer of Tryp Therapeutics aims to reduce the time patients spend in a dissociative state by enhancing the effectiveness of formulation, delivery, and dosing of psychedelic compounds.
Field Trip Health Scores Huge Funding Round
Toronto-based Field Trip Health (CSE: FTRP), founded in 2019, is on a tear closing a common share deal worth a total of $95 million. With this successful round of funding the company seeks to develop FT-104, their psilocybin like molecule and expand their clinic network.
This field trip will be shorter
Portions of the cash will go towards financing the development of FT-104, which Field Trip hopes will last just 2 to 3 hours, yet still offer similar clinical results.
A promising growth
In this round, they scored big from several investors which included Avidity Partners, Jennison Associates, Pura Vida Investments, Soleus Capital, Sphera Funds, and more.
- In March of 2020, the company opened its first ketamine-assisted clinic in Toronto.
- They operate clinics in Amsterdam, Atlanta, Chicago, Los Angeles, and New York.
- Because FT-104 is a novel molecule, it can be patented and will provide an attractive ROI for investors.
- They are aiming for FT-104 to enter Phase 1 clinical trials before the end of 2021, and hit the market with a product by 2026.
Canada’s new ‘Centre of Clinical Excellence‘ will provide psychedelic therapy for veterans and first responders with PTSD.
DMT (Dimethyltryptamine) is being trialed as a potential cure for depression for the first time, and a ketamine-assisted therapy clinic is set to open in Bristol.
Psilocybin, ayahuasca, and mescaline are now decriminalized in DC.
CURE’s (OTC: CURR) patented oral film platform intends to optimize the absorption and metabolism of psychedelic actives targeting clinical efficacy of both macro-dosing and micro-dosing treatment regimens.
Cybin (NEO: CYBN) progresses two IND candidates, and announces completion of its 20th pre-clinical study.
Algernon Pharma (CSE: AGN) filed a pre-IND meeting request with the FDA for its investigation of DMT to treat stroke-related dysfunction.
Perception Neuroscience and Otsuka Pharma announce collaboration on development of Ketamine in Japan for treatment-of depressive disorders.
The Australian federal government has committed $15 million for the development of psychedelic drug therapies for mental illness.
Oregon is moving forward in creating a framework program to allow psilocybin to be used for medical purposes, with the formation of a Psilocybin Advisory Board.
The New York Times is going deep on shrooms.