The Bodhi Project
The Bodhi Project is devoted to seeking FDA approval for generic ketamine for a mental health diagnosis in a ketamine-assisted psychotherapy (KAP) framework. Receiving FDA approval for KAP will help millions of people suffering from depression who are not being served by the current treatments. It will allow medical insurers and large healthcare systems to provide this lifesaving treatment in an ethical and low-cost way to marginalized communities that would most benefit.
By demonstrating the utility of ketamine in clinical treatment, we can add this medication to the toolbox for mental health clinicians, and enable access to a safe and legal psychedelic experience. Our goal is not financial but to set a precedent of putting people over profits. This is for the benefit of other Beings, and thus, a Bodhisattva project.
The Bodhi Project is a collaboration between People Science, Valis Bioscience, and The Lundquist Institute. The founders of these organizations have collectively donated hundreds of hours already for the benefit of the community-at-large.
Belinda Tan MD, PhD
People Science
Christian Yavorsky, PhD
Valis Bioscience
Noah Craft MD, PhD
People Science
Why is ketamine so important?
Ketamine was developed in the 1960s as a surgical anesthetic for humans. In recent years, it was discovered that ketamine has rapid-acting antidepressant properties and has been shown to help people suffering from depression who have failed to improve on other antidepressant treatments (1).
Racemic ketamine is a cheap generic medication which is broadly available to licensed providers as medical supply. It is currently FDA-approved for surgical and procedural sedation and pain management, but not for mental health conditions. Despite being safe and affordable, medical insurance companies and public health programs routinely deny patients access to ketamine, citing the lack of FDA approval (6).
So far, no pharmaceutical company or institution has been motivated to pursue FDA approval for generic ketamine as it is not financially rewarding. The Bodhi Project is on a mission to improve patient care and increase safe access to ketamine treatment. Together we will set an important precedent for the use of other medicines with psychedelic properties and help the millions in need.
Additional educational resources:
Ethical Guidelines for Ketamine in Mental Health
Promise, Power, and Profit: The Economics of Ketamine Treatment
References
Bahji A, Zarate CA & Vasquez GH (2022). Efficacy and safety of racemic ketamine and esketamine for depression: a systematic review and meta-analysis, Expert Opinion on Drug Safety.
Brooks M (2023) IV vs intranasal ketamine: Which is best? In: Medscape.
Chen L (2021). Canada's Federal Court of Appeal confirms Janssen's Spravato not eligible for data protection, JDSupra.
Jelen L, Young A & Stone J (2020). Ketamine: a tale of two enantiomers, Journal of Psychopharmacology.
Nasal spray medicine for treatment-resistant depression not recommended by NICE. https://www.nice.org.uk/news/article/nasal-spray-medicine-for-treatment-resistant-depression-not-recommended-by-nice#:~:text=The%20cost%2Deffectiveness%20estimates%20for,guidance%20is%20subject%20to%20consultation.
Ramos MA, Boyd JW & Alpert MD (2019). Opinion: the new ketamine-based antidepressant is a rip-off, Vice.