Psilocybin

2024 saw significant drug policy changes, including Kamala Harris's pledge to federally legalize cannabis, and rescheduling of cannabis to Schedule III. Lenacapavir, a new HIV prevention drug, was named breakthrough of the year. Weight loss drugs like Ozempic and Wegovy showed potential for treating addiction and neurodegenerative diseases. Overdose deaths declined nationally for the first time since the 1990s, though racial disparities persist. Psychedelics faced setbacks with FDA not approving MDMA for PTSD and Massachusetts rejecting a ballot measure for home-use of psilocybin. The White House accused Syria's Assad of profiting from Captagon sales, leading to its destruction and potential relocation of manufacturing. 'Pink cocaine' gained popularity, posing risks due to its unknown composition.

Avextra partners in PsyPal, a Horizon Europe-funded Phase 2 trial examining psilocybin-assisted therapy for palliative care patients with COPD, MS, ALS, and APD. The multi-centre study, spanning four European countries, aims to evaluate safety, efficacy, and long-term impact, while also considering caregiver effects. Coordinated by the University Medical Center Groningen, the consortium includes 19 organizations from nine countries.

In 2023, Biden Administration recommended cannabis reclassification, with progress continuing into 2024. The FDA rejected MDMA-assisted therapy for PTSD in August, with another clinical trial planned. Boulder's Cannabis Licensing and Advisory Board considered a marijuana concentrates ban, which the industry opposes. Colorado prepared for psychedelic healing centers, with training programs approved and licenses available from December. Naropa's psychedelic program was delayed but will be run by Memoru Center. Healing centers will initially use psilocybin and psilocin, with potential expansion to other substances in 2026.

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Psyence Biomedical updates on Phase IIb trial of nature-derived psilocybin with psychotherapy for adjustment disorder in palliative care patients. Trial includes 87 patients, two Australian sites activated, and first site initiation visit completed on Sept 9, 2024. First patient randomization expected in Jan 2025, with topline results anticipated in H2 2025. Psyence Biomed partners with ACTioN SMO for patient recruitment.

Psyence Biomedical's Phase IIb trial of nature-derived psilocybin with psychotherapy for Adjustment Disorder in Palliative Care progresses with two Australian sites activated and patient screening underway. First patients expected in January, with therapist training ongoing. Additional sites under evaluation, and ACTioN SMO aiding recruitment through social media and direct communications.

Psyence Biomed's Phase IIb trial for nature-derived psilocybin with psychotherapy in Adjustment Disorder following cancer diagnosis progresses, with two Australian sites activated and patient screening underway. First patients expected to be randomized in January, with ACTioN SMO aiding recruitment through social media and direct communications. Topline results anticipated in H2 2025.