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US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. The draft guidance is intended to advise researchers on aspects such as clinical study design as they develop medications that contain psychedelics.

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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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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.

FDA 96
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Psychedelic medicines: are they gaining traction in Europe?

European Pharmaceutical Review

Psychedelics are a class of psychoactive substances that produce temporary changes in perception, mood and cognitive processes. 1 Some psychedelics are found in nature, including psilocybin, a naturally occurring molecule found in almost 150 species of mushrooms which turns into psilocin once ingested, causing psychedelic effects.

Medicine 114
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Avoiding a ‘bad trip’ in psychedelic clinical trials

PharmaVoice

Psychedelic drug trials pose a number of challenges, but researchers can take these steps to boost patient safety.

Safety 100
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Psychedelic research: evaluating the fast-evolving regulatory roadmap

European Pharmaceutical Review

Psychedelic research, in particular, is gaining momentum. . Regardless, most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use. Up until recently, it took a prohibitive stance toward psychedelic research.

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atai invests $50m in Beckley Psytech

pharmaphorum

Beckley Psytech has announced that is has received substantial strategic investment from atai Life Sciences, totalling $50 million, to accelerate the clinical development of short-duration psychedelics.

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