FDA Approval for Generic Ketamine for Mental Health
We need FDA approval for generic (racemic) ketamine for mental health. Ketamine has been demonstrated in numerous studies to be an extremely useful tool in psychiatry and psychotherapy (1, 2). However, generic ketamine is not currently FDA approved for any mental health application (3, 4). Therefore, many medical insurance companies refuse to pay for therapeutic ketamine services; large healthcare organizations and community clinics are largely unable to offer these services; and practitioners risk being penalized for utilizing it in their clinical practices. Further, no company or institution is motivated to pursue FDA approval for generic ketamine for mental health; it is not profitable to get FDA approval for a generic medication.
So we have decided to step up. This project is a collaboration between People Science, KRIYA Institute, Valis Bioscience, and The Lundquist Institute. The principals for this project are accomplished healthcare professionals and researchers who have previous experience in earning FDA approval for other psychiatric medications and medical treatments.
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We are pursuing FDA approval for generic ketamine for mental health. We have created a thoughtful plan to navigate the arduous FDA approval process. Through clinical trials, we will study the clinical efficacy of generic ketamine paired with psychotherapy (KAP) for people with substantial depression who have not responded adequately to previous treatment. Currently, we are preparing our FDA pre-IND submission.
Our goals are to unlock medical insurance coverage for therapeutic ketamine services and demonstrate the clinical efficacy of Ketamine-Assisted Psychotherapy (KAP). Our mission is to increase access to mental health care for millions of people.
This Bodhisattva Project is for the benefit of other people. We have no commercial product to sell. Collectively, we have donated hundreds of hours already. We are very grateful for your help and support in this endeavor.
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Additional educational resources:
Ethical Guidelines for Ketamine in Mental Health
Promise, Power, and Profit: The Economics of Ketamine Treatment
Nasal spray medicine for treatment-resistant depression not recommended by NICE
- 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.
- Jelen L, Young A & Stone J (2020). Ketamine: a tale of two enantiomers, Journal of Psychopharmacology.
- Ramos MA, Boyd JW & Alpert MD (2019). Opinion: the new ketamine-based antidepressant is a rip-off, Vice.
