Psychedelics are among the hottest things on the market right now. As more and more studies have indicated that these hallucinogenic drugs can have significant mental health benefits, especially when paired with psychotherapy, interest in psychedelic research has increased significantly.
Scientists from around the world are now preparing or already running studies to determine the efficacy of psychedelics such as psilocybin and LSD against mental health conditions such as post-traumatic stress disorder, depression and eating disorders.
With the psychedelics drugs market projected to be worth $10.75 billion by 2027, plenty of individual and institutional investors are looking to buy in while the industry is still in its infancy. The resulting flow of investment dollars into the field of psychedelic research has been followed by a multitude of clinical trials by companies looking to develop their own proprietary psychedelic medications and bring them to market.
Director of neuropharmacology at biotechnology company Cybin, Dr. Amy Reichelt, recently outlined the steps that psychedelic companies have to go through during the clinical trial process. First, Reichelt stated, the process starts at the discovery phase with companies developing novel molecules from psychedelic compounds and testing their capabilities. The neuroscientist explained that they test the properties of these substances at the molecular level before using the data they generate to advance to the next step: preclinical research.
During this step, researchers test the effect of these novel molecules on animal subjects, usually mice, studying the subjects’ reactions to gauge if the molecule has created any hallucinogenic effects. This stage of research also involves studying toxicology reports to determine if the molecules are safe for use in animal models before they can be used in human models.
Reichelt noted that the researchers had to make sure the novel molecules were safe and would not result in any adverse health effects on the test subject. Once they have a sufficient amount of research data at this level, Reichelt said, companies can create an investigational new drug (IND) package. This is a package that contains information on the novel molecules, such as how they were absorbed by the test subject, how the molecule was distributed around the subject’s system, whether the molecule had any adverse physiological effects and how it cleared from the subject’s body.
According to Reichelt, the preclinical trial process can take an average of seven years for companies in the pharmaceutical industry.
Researchers can then move on to phase 1 trials involving healthy human volunteers if their procedures are backed up by solid data and if their IND package is approved by the appropriate drug regulator. She notes that every single step during clinical trials has to be prescreened, approved, transparent and aligned with Good Clinical Practice.
This is the process that all entities, including Field Trip Health Ltd. (OTC: FTHWF) (TSX: FTHW), have to follow in order to get the remedies they develop approved by the FDA and other such regulators.
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