FDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
There is growing interest in the use of psychedelic-assisted therapy for treatment of mental health conditions. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial.
Canadian and US developers of psychedelic medicines for complex mental health conditions have signed with a UK-based CMO to trial their drugs in London.
According to a new study, 25mg of psilocybin alongside psychological support, greatly reduces symptoms in participants with treatment-resistant depression.
COMP360 25mg versus 1mg comparator dose demonstrated a -6.6 point difference on the Montgomery-Åsberg Depression Rating Scale by week 3.
Here, Dr Matthew McMurray and Dr J Andrew Jones of Miami University explain why psychedelic drugs are attracting R&D as potential treatments for neuropsychiatric and degenerative disorders and how their discovery of an in vivo production technique could enable further advancement.
The largest placebo-controlled psychedelics study to date concluded that the psychological benefits of microdoses of psychedelics are likely due to the placebo effect.
The Terasaki Institute is partnering with PharmaTher to adapt a microneedle drug delivery patch for the micro-dosing of psychedelics.
In a new study, COMP360 (psilocybin) was well tolerated in healthy volunteers which support further investigation of a simultaneous 1:1 therapeutic administration design.