Adequately addressing the issues of compliance, standardization, and oversight is crucial to the successful entry of entheogens into the modern medical discussion. Entheon Biomedical recognizes that the use of psychedelic medicine is currently a legal grey area in most jurisdictions, and comes with both legal and medical risks.
Entheon Biomedical is undertaking the painstaking work of entering these drugs into a medically and scientifically rigorous FDA, EMA, and Comment start Health Canada Comment end approval model, thereby creating safe and legal products for consumption. We are committed to connecting the insights of previous research, the wisdom of indigenous cultures, and scientifically irrefutable data, to develop the evidence-based treatment processes the world needs.
Entheon Biomedical is working to formulate proprietary combinations of psilocybin and other molecules for specific therapeutic applications that target addiction and substance-related disorders. By developing a multitude of dosing strategies, it is researching the creation of a variety of treatment protocols that can be deployed to assist in a variety of treatment scenarios.
Our science board is comprised of experts in the field of neuropharmacology, genetics, psychiatry and substance use disorder. Scientific rigour is crucial to not only efficacy, repeatability and safety, but also compliance. Entheon Biomedical is taking all necessary steps to ensure that the products consumers use are tested to the rigours of the regulatory approval process.
We are currently preparing to initiate our preclinical trials with CROs and Universities to yield our baseline toxicology data. Animal behavioural trials are expected to follow shortly thereafter to determine if the administration of our formulations yield reductions in drug seeking behaviour, and increased sociability in our test animals.
Assuming successful results of our animal studies, Entheon Biomedical would then commit to one of the licensed research organizations it is in dialogue with to begin the work of carrying out human trials in a strict academic environment, yielding data to be put toward its FDA, EMA and Canada Health approval applications.