Ceruvia Lifesciences Drug Trials Work To Turn Psychedelic Research Into Medicine for OCD, Headache Disorders
Synthetic psilocybin and BOL-148 — a non-psychedelic LSD derivative — appear to produce better results than current treatments.
Ceruvia Lifesciences is pursuing groundbreaking clinical trials to treat conditions such as migraine, cluster headache and obsessive-compulsive disorder.
Greenwich, Conn. – Ceruvia Lifesciences is channeling funding into clinical trials for difficult-to-treat conditions with great unmet need including headache disorders and OCD.
Ceruvia Lifesciences (formerly CH-TAC) is pursuing FDA approval for these new treatments.
Synthetic psilocybin and BOL-148 — a non-psychedelic LSD derivative — appear to produce better results than current treatments.
Ceruvia Lifesciences is the first to produce LSD and BOL-148 with manufacturing processes adhering to the highest standards required by the European Union and US regulatory agencies.
The company is supplying academic research sites with free LSD to support clinical research. Psilocybin and LSD have been shown to be safe when administered in a therapeutic setting.
Since 2015, Yale University has been the site of Ceruvia Lifesciences’ research to treat disorders including cluster headache, migraine and OCD. The university is key to advancing the research. Ceruvia Lifescience has established additional collaborations with Harvard Medical School, New York University School of Medicine, Usona Institute, Heffter Research Institute and Clusterbusters, a nonprofit for cluster headache sufferers.
Ceruvia Lifesciences’ Founder & CEO Carey Turnbull has been working to advance psychedelic research for more than a decade. Turnbull, as a fundraiser and donor, has contributed more than $30 million to psychedelic research. He is a board member of the Usona Institute and President of the Heffter Research Institute, and has worked in commercial early-stage drug development for half a dozen companies variously as an investor, founder, and CEO since 2010.
He also co-founded B.More, a company pursuing groundbreaking clinical trials to treat alcoholism with synthetic psilocybin, and Freedom to Operate, a nonprofit protecting psychedelic science and medical development for public benefit.
Ceruvia Lifesciences is initiating Phase 2 clinical trials of the FDA prescription approval process to evaluate the effectiveness of synthetic psilocybin on OCD. This could bring relief to the 3.9 million patients diagnosed with OCD in the US cited by the National Institute of Mental Health.
The compounds have shown promising results in early clinical trials. Unlike traditional medicines prescribed to treat mental disorders or pain, the medical compounds being studied appear to have long term effects after a brief treatment.
“There’s a very long lasting effect, which is not seen with these other drugs you have to take every day,” said Kay Monroe, Ceruvia Lifesciences COO. “Psychedelic medicines demand to be looked at, because their mechanism of action is very different from traditional drugs, and because you don’t have to take them every day. Side effects are reduced if you don’t have to take a drug daily.”
Research suggests this benefit could be a result of how psychedelics transform the brain. Psychedelics promote synaptic growth and result in “rewiring” the brain producing long-lasting results. This appears to be the case even for compounds like BOL-148, which is chemically similar to LSD but produces no hallucinations.
In a pilot study by Harvard Medical School and Hannover Medical School, 100 percent of the patients reported significant relief from cluster headaches after receiving 3 doses of BOL-148, even when tracked over 16 weeks. Cluster headaches are typically described by sufferers as being more painful than childbirth or gunshot wounds.
Ceruvia Lifesciences owns a patent license from Harvard on BOL-148 to treat cluster headache. Their formulation is called “NYPRG-101.” BOL-148 was originally developed as a placebo and has been safely administered pre-clinically and clinically to approximately 300 people.
The company is also moving new treatments for alcoholism and opioid addiction forward with an experienced group of leading institutions, innovative collaborators, partners, academia and industry experts.
The Migraine Research Foundation says 39 million in the US suffer from migraines and 1 billion worldwide.
“Ceruvia Lifesciences is pursuing FDA approval to treat headache disorders, OCD, opioid addiction and alcoholism because the current treatments do not provide adequate results,” Turnbull said. “The large populations suffering from those conditions need better solutions.”
Ceruvia Lifesciences researches, develops, and manufactures medicines based on psychedelic research to address challenging hard-to-treat disorders, such as headache disorders and OCD. More information is available at https://ceruvialifesciences.com.
Contact Info:
Carey Turnbull, CEO
Ceruvia Lifesciences, LLC
info@ceruvialifesciences.com
15 East Putnam Avenue, Suite #413
Greenwich, CT 06830
https://ceruvialifesciences.com
Seeking opportunities to create new transformational medical breakthroughs
Fund
Create significant health impact by providing targeted funding that focuses on providing relief to marginalized sufferers and ultimately making a difference in millions of people’s lives.
We fill a significant gap in the psychedelic and related drug industry (>$1.2bn/annum) that current organizations do not pursue, positioning us as leaders in this space.
Provide Evidence
Continue to generate data from controlled clinical trials in academic settings at leading institutions.
We fund and work with innovative collaborators and partners to discover and develop promising medicines to treat challenging disorders.
Ceruvia Lifesciences is built on sound science and has gathered key, experienced consultants and scientific advisors to advance projects.
Advance
We are the world’s first producers of GMP LSD, which we supply to academic research sites, and GMP BOL-148.
We adhere to the highest development, testing, and manufacturing standards as established by regulatory authorities as well as pharmaceutical industry associations and organizations.
Commercialize
We envision a future where Ceruvia Lifesciences can deploy treatments to create a significant benefit for all stakeholders in our focus areas: patients, caregivers, payers, and health care providers.
Meet Our Collaborators and Partnerships
Since 2015, Yale University has been the site of Ceruvia Lifesciences’ research to treat Cluster Headache, Migraines, and OCD and and is key to our life science efforts.
Usona Institute is a non-profit medical research organization dedicated to supporting and conducting pre-clinical and clinical research to understand further the therapeutic effects of psilocybin and other consciousness-expanding medicines. Their focus is on alleviating depression in people whose current medical treatments fall short in offering relief and a better quality of life.
Usona has manufactured pharmaceutical-grade psilocybin and is currently conducting the necessary comprehensive pre-clinical toxicology work for prescription medication, enabling Ceruvia Lifesciences’ FDA clinical trials.
The Heffter Research Institute promotes the highest-quality scientific research with classic hallucinogens and related compounds (sometimes called psychedelics) to better understand how the mind improves the human condition and alleviates suffering.
Ceruvia Lifesciences seeks to take academic research Heffter has been instrumental in developing at elite universities and pivot it into prescription medication development trials required by FDA.
New York University (NYU), one of the nation’s premier academic medical centers, has newly created the NYU Langone Center for Psychedelic Medicine, which conducts trials for Ceruvia Lifesciences focusing on substance abuse disorder research.
Clusterbusters is a patient advocacy group that supports research for better headache disorders treatments while advocating to improve the lives of those struggling with cluster headaches. For the past ten years, their advocacy has been an essential tool for Ceruvia Lifesciences programs.