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Experts Weigh in on FDA’s Draft Psychedelics Research Guidelines

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For the past several years, a flurry of psychedelic-related research has found that hallucinogenic drugs have various applications in the mental health field. Researchers have found that pairing talk therapy with psychedelics is incredibly effective at alleviating conditions such as depression, anxiety and post-traumatic stress disorder.

Several years after psychedelics began gaining steam as alternative mental health treatments, the U.S. Food and Drugs Administration has finally issued guidance on the management of psychedelic clinical trials. Even though initial results have been incredibly encouraging, significantly more research and clinical trials are needed before psychedelic-based treatments are developed and deployed to the mass market.

The draft guidance published by the FDA in late June 2023 is meant to provide protocols and regulations for future clinical trials involving psychedelics. It offers guidance on the creation of clinical studies to study hallucinogenics such as LSD, psilocybin (magic mushrooms) and MDMA along with their effectiveness in mental health treatment.

According to a statement from an FDA spokesperson, psychedelics present a “very active and challenging area of drug development.” The agency spokesperson noted that there is limited experience in creating programs to study psychedelics for FDA approval due to the novelty of the field.

Compass Pathways, one of the largest companies taking part in psychedelic research, had revealed that it was expecting the draft guidance based on past communications with the FDA. The company is currently running phase 3 studies on the safety and efficacy of psilocybin, the main psychoactive component in magic mushrooms. A Compass Pathways spokesperson said that the company is pleased to see that the draft guidance from the regulatory agency is in line with its own policies, especially on rigor and exceedingly high standards.

Pathways’ clinical trials are already designed with similar protocols in mind and will not need any further change in the face of the draft regulations, the spokesperson said. Researchers in academic institutions studying psychedelics have also praised the draft regulations, stating that they provide much-needed guidance for the nascent but swiftly growing field of psychedelic research.

However, some experts are not pleased with certain requirements included in the draft provisions such as a recommendation that psychedelic clinical trial subjects must be observed by two monitors during treatment. One of the monitors should be a healthcare professional with “graduate-level professional training” and psychotherapy experience and the other should have a degree and at least one year of clinical experience in mental healthcare.

Paul Hutson, PharmD, MS, director of the Transdisciplinary Center for Research in Psychoactive Substances at the University of Wisconsin in Madison, that this will be one of the most disputed aspects of the draft regulations. Hutson explained that the provision could derail efforts to study psychedelics by overburdening research teams.

More views on the research guidelines can be expected from enterprises such as Seelos Therapeutics Inc. (NASDAQ: SEEL) as the comment period progresses.

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