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What the FDA’s groundbreaking guidance really means for psychedelic therapy clinical trials

pharmaphorum

What the FDA’s groundbreaking guidance really means for psychedelic therapy clinical trials Mike.Hammerton Wed, 29/11/2023 - 10:00 Bookmark this

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FDA publishes recommendations on psychedelic clinical trial design

European Pharmaceutical Review

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. The draft guidance is intended to advise researchers on aspects such as clinical study design as they develop medications that contain psychedelics.

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Navigating Research in Psychedelics: Investigators Face a Mosaic of Regulations, False Perceptions, and Therapeutic Potential

Pharmacy Times

If clinical trials continue to show that psychedelics offer safe and long-lasting results, then psychedelic-assisted therapy could flourish as a treatment in the mental health space.

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ICER raps conduct of Lykos’ psychedelic trial for PTSD

pharmaphorum

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

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Navigating the Psychedelic Renaissance: Emerging Mental Health Therapies and the Pharmacist’s Role

Pharmacy Times

Psychedelic medicines such as psilocybin, MDMA, ketamine, and LSD have been shown to have a significant impact on conditions such as major depressive disorder, generalized anxiety disorder, and post-traumatic stress disorder in clinical trials.

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Psychedelic-Assisted Therapy Is Life-Changing for Veterans With PTSD, Yet Access to These Therapies Remain Outside the United States

Pharmacy Times

In the clinical setting, psychedelic medicine has promise as a safe and efficacious treatment for PTSD, TBIs, and other mental health issues.

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Cybin bags breakthrough tag for psychedelic depression drug

pharmaphorum

Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.

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