Psilocybin

The reelection of former President Donald Trump and Republican gains in Congress raise questions about the impact on FDA regulation of drugs and devices. Key areas to watch include new agency heads and priorities, potential decreases in federal oversight, reproductive rights, marijuana rescheduling, supply chain policies, vaccine and novel treatment approaches, OTC drugs, and digital health technologies. The industry is poised for significant changes under the new administration.

Veterans face significant mental health challenges post-deployment, with 22-44 suicides daily. New treatments like psilocybin for drug-resistant depression and PTSD are needed. Senate Bill 3695 aims to expand research on medicinal psilocybin use in clinical settings.

Massachusetts voters will decide on legalizing psychedelics for therapeutic use, with proponents citing mental health benefits and opponents warning of public safety risks. The measure would allow personal use and cultivation of certain psychedelics, establish licensed treatment centers, and is supported by personal stories of transformation and healing, despite concerns over unregulated access and potential harms.

Miami University researcher Andrew Jones uses bioreactors to produce psilocybin and other psychedelics, attracting attention and funding. Despite FDA setbacks like rejecting Lykos Therapeutics' MDMA application, interest in psychedelics for treating PTSD, depression, and addiction remains high. Jones' lab synthesizes compounds for consistency and safety, and he collaborates on research into psilocybin's neuroplastic and anti-inflammatory effects. Public acceptance of psychedelics is growing, with legal psilocybin therapy available in Oregon, and ongoing research worldwide.

Psilocybin, the active hallucinogen in magic mushrooms, has shown promise in treating Major Depressive Disorder and Treatment-Resistant Depression. With a breakthrough designation from the FDA, clinical trials are expedited. A study estimates over 5 million people could benefit from psilocybin-assisted treatment, potentially reducing the financial burden on insurance payers.

Key opinion leaders highlight unmet needs in Parkinson’s disease (PD) treatment, including lack of neuroprotective/disease-modifying therapies (DMTs) and non-motor symptom treatments. No DMTs are currently marketed; PD products focus on symptomatic relief. The PD drug development pipeline in 7 major markets emphasizes neuroprotective and DMTs, with 66% targeting these needs. Anti-alpha-synuclein therapies face skepticism due to safety concerns. There is also focus on non-motor symptoms, with 18% of the pipeline addressing symptom management beyond core motor symptoms.

Paul Stamets' work highlights the potential of fungi, particularly mushrooms, to improve human life and address global issues, advocating for more research and responsible use of psilocybin.

Psilocybin, the active chemical in “magic mushrooms,” may help treat anorexia, with 4 of 10 study participants showing significant reductions in anorexia-driven eating habits. The study involved 10 adult women with anorexia receiving a single 25-milligram dose of synthetic psilocybin combined with psychological support. Nine out of 10 women ranked the session among their top five most meaningful life experiences. However, the psychological changes did not automatically translate to weight restoration.

CIIS to offer first B.S. in psychedelic studies in 2025, combining psychology, anthropology, and neuroscience. The program responds to growing demand for psychedelic therapy training, projected to reach $4.6 billion by 2030. CIIS emphasizes ethical integrity and consent in psychedelic therapy, addressing past scandals. The degree is designed for juniors and seniors, focusing on therapeutic uses without hands-on drug experiences.