FDA Issues First Draft Guidance On Clinical Trials With Psychedelic Drugs
Portfolio Pulse from Benzinga Newsdesk
The FDA has issued its first draft guidance on clinical trials for psychedelic drugs, providing researchers with considerations for designing studies to evaluate the safety and effectiveness of these compounds. The guidance covers drugs such as psilocybin, LSD, and MDMA, and aims to help researchers design studies that will yield interpretable results for future drug applications.
June 23, 2023 | 2:33 pm
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FDA's first draft guidance on clinical trials for psychedelic drugs may impact Compass Pathways, a company researching psilocybin therapy for treatment-resistant depression.
The FDA's draft guidance on clinical trials for psychedelic drugs will provide researchers with a framework for designing studies, which may impact Compass Pathways' ongoing research on psilocybin therapy for treatment-resistant depression. The guidance may help streamline the research process and potentially expedite the approval of new treatments.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80
POSITIVE IMPACT
Cybin Inc., a company focused on psychedelic drug development, may be impacted by the FDA's first draft guidance on clinical trials for psychedelic drugs.
The FDA's draft guidance on clinical trials for psychedelic drugs will provide researchers with a framework for designing studies, which may impact Cybin Inc.'s ongoing research and development of psychedelic drugs. The guidance may help streamline the research process and potentially expedite the approval of new treatments.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80
POSITIVE IMPACT
MindMed, a company researching psychedelic-inspired medicines, may be impacted by the FDA's first draft guidance on clinical trials for psychedelic drugs.
The FDA's draft guidance on clinical trials for psychedelic drugs will provide researchers with a framework for designing studies, which may impact MindMed's ongoing research on psychedelic-inspired medicines. The guidance may help streamline the research process and potentially expedite the approval of new treatments.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80