Psychedelic reform is gaining traction in the United States as more states introduce measures to decriminalize and legalize the use of these substances. This is primarily due to a significant increase of interest in these drugs in the recent years as more studies uncover the therapeutic benefits that psychedelics possess.
Thus far, numerous studies have found that psychedelics such as MDMA, psilocybin and ketamine may help manage symptoms of anxiety and depression, reduce OCD symptoms, improve mood and improve symptoms of post-traumatic stress disorder. In 2017, the FDA even granted breakthrough therapy designations to psychedelic therapies using psilocybin to treat depression and MDMA for the treatment of PTSD.
Some biopharma companies have gone a step further and began developing psychedelic-based treatments for a range of mental health conditions. For example, MindMed, a psychedelics-focused pharmaceutical company, is currently researching the use of its proprietary LSD formulation as an alternative treatment for major depressive disorder patients, as well for those living with ADHD and generalized anxiety disorder. The company was the first in the field to go public in the country.
Earlier in January, Small Pharma, another biotechnology company, released positive results from a phase 2 DMT trial that explored the drug’s effectiveness in treating major depressive disorder. In 2021, the Multidisciplinary Association for Psychedelic Studies concluded a phase 3 clinical trial, which reported positive results for MDMA in treating PTSD when it was administered together with psychotherapy.
In addition to these established companies, some startups are also entering the field. For instance, COMPASS Pathways announced in 2022 that its synthetic psilocybin formulation had shown an 86% remission rate in patients with type II bipolar disorder. This announcement followed efforts by Sensorium Therapeutics to raise millions in funding for the development of psychoactive molecules for neuropsychiatric illnesses.
A shift in the U.S. government’s approach to how psychedelics are regulated will also influence the market’s growth positively. With regard to research and access, the FDA’s giving a go-ahead to psychedelic therapies will remove the barriers restricting research as well as those limiting patient access.
At the moment, however, hallucinogenic drugs such as psilocybin and MDMA remain classified as Schedule I drugs under the Controlled Substances Act. Drugs under this classification are said to have a high potential for abuse and are not currently accepted for medical use.
As startups such as Field Trip Health Ltd. (OTC: FTHWF) (TSX: FTHW) continue to register progress in their psychedelics R&D programs, the classification of psychedelics under federal law could evolve from its current restrictive stance.
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