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The New England Journal of MedicinePerspective: How Should the FDA Evaluate Psychedelic Medicine?

The Food and Drug Administration (FDA) is at the forefront of a new era in mental health treatment, with psychedelic medicine gaining traction as a viable therapeutic option. As drug companies invest millions into psychedelic research, the FDA’s guidance on this emerging field is shaping the future of mental health care, with implications for clinicians, researchers, and patients alike.

Key Points

  • The FDA’s guidance recognizes the potential of psychedelics, such as LSD and psilocybin, in treating mental health disorders.
  • The guidance suggests that new human trials may be allowed without animal testing if previous trials have not identified serious safety concerns.
  • The FDA proposes minimizing “functional unblinding” in placebo-controlled trials by administering subperceptual doses of psychedelics.
  • The FDA recommends excluding participants with valvular disease or pulmonary hypertension due to a potential risk associated with 5-HT2B agonists.
  • The guidance urges sponsors to justify the inclusion of psychological support and describe plans to quantify its effects and reduce potential bias.
  • The FDA classifies the subjective effects of psychedelics as “abuse-related adverse events” and urges sponsors to report these events as safety concerns.

According to a study published in the Journal of Psychopharmacology, psilocybin, a psychedelic compound found in magic mushrooms, has shown promise in treating depression and anxiety in patients with life-threatening cancer.

More on Psychedelics

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