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In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
Research suggests that for every five mothers given low dose esketamine, one major depressive episode could be prevented.
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
The first antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor has been approved for major depressive disorder (MDD) by the US Food and Drug Administration (FDA).
A Phase Ib study evaluating selective serotonin reuptake inhibitors (SSRIs) interaction with SPL026, native N, N-dimethyltryptamine (DMT) in major depressive disorder (MDD) has revealed positive data.
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
Articles explore the potential of tryptamines in treatment-resistant depression and drug delivery options for mRNA therapeutics.
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.
According to a new study, 25mg of psilocybin alongside psychological support, greatly reduces symptoms in participants with treatment-resistant depression.
Phase III data shows most major depressive disorder patients treated with zuranolone had minimal or mild depressive symptoms after a year.
A new pre-clinical study succeeded in the intranasal delivery of an anti-depressant peptide-based drug to the brain in mouse models.
COMP360 25mg versus 1mg comparator dose demonstrated a -6.6 point difference on the Montgomery-Åsberg Depression Rating Scale by week 3.
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
