Psilocybin

DEA increases 2025 DMT production quota to 20,000 grams to support FDA-approved drug development, citing research needs and public comments. Several companies are exploring DMT for treating mental health conditions and brain injuries.

Psyence Biomed reports progress on its Phase IIb clinical trial testing nature-derived psilocybin with psychotherapy for Adjustment Disorder in palliative care cancer patients. Two Australian trial sites, Vitalis and EMPAX, have been activated with patient screening underway. The company expects to begin patient randomization in January and anticipates topline results in the second half of 2025.

Oregon's psychedelic program, focusing on psilocybin treatment, saw its first full year in 2024 with hundreds of trained specialists and thousands of treatments completed with few adverse effects. The program aims to refine and study its impacts in 2025, addressing issues of cost, availability, and insurance coverage. Preliminary research results are expected in early 2025, potentially influencing policy and insurance coverage.

Avextra leads EU-funded PsyPal project, a Phase II study on psilocybin-assisted therapy for palliative care patients with depression, funded by a €6.5 million grant from Horizon Europe. The study, starting in 2025, involves 19 partners across 9 European countries, aiming to evaluate safety, efficacy, and impact on mental health, well-being, and quality of life for patients with life-limiting diseases and their caregivers.

Psyence Biomed (Nasdaq: PBM) has executed binding agreements with Optimi Health Corp, securing exclusive worldwide supply of GMP-certified, nature-derived psilocybin for Palliative Care drug development. Optimi will also provide comprehensive Chemistry, Manufacturing, and Control (CMC) support for regulatory submissions, aiding Psyence's Phase IIb clinical trial for Adjustment Disorder in Palliative Care and future Phase III studies.

Illinois lawmakers explore psychedelics, specifically psilocybin, as a potential treatment for behavioral health issues. The Illinois CURE Act aims to legalize psilocybin for medical purposes, creating a state-regulated program. Psilocybin, currently a Schedule I drug, has been granted 'breakthrough therapy' status by the FDA.

Recent studies show psilocybin can treat severe depression and PTSD by promoting neuroplasticity. Peter Silverstone, a psychopharmacology expert, highlights psychedelics' potential as a mental health breakthrough. Despite risks, supervised use shows promise, with Alberta leading in psychedelic therapy regulation and insurance coverage. Caution is advised due to potential risks and hype.