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Replies to post #8140 on Mind Medicine (MindMed) Inc (MNMD)
Ceruvia Lifesciences, a biopharmaceutical company, announced that it has produced the world's first LSD that meets stringent "Current Good Manufacturing Practices" (CGMP) standards required by the FDA for new drug approvals and is offering to supply it at no cost to qualified researchers.
Ensuring the availability of a supply of CGMP LSD will be a key factor in advancing research into LSD's safety and efficacy for the treatment of a range of neurological, mental health and neurodevelopmental disorders, including cluster headaches, migraines, alcohol use disorder, opioid use disorder, anxiety and attention deficit disorder, according to a company press release.
Along with providing a free supply for researchers studying LSD’s potential benefits on these mental health conditions, the company will produce its CGMP LSD for the first US-based trials with human subjects in many years at two of the country’s leading psychedelic research centers: NYU Langone’s Center for Psychedelic Medicine and Johns Hopkins’ Center for Psychedelics and Consciousness Research.
As Stephen Ross, MD, associate director of NYU Langone's Center for Psychedelic Medicine put it, "We are very excited about our research examining the potential benefits of LSD in managing cancer-related pain. This work builds on earlier studies from decades ago when LSD was originally thought to be a compound with enormous potential."
The fact is, it’s taken forty years for LSD trials to re-gain approval from the FDA, which makes this announcement a promising one as it marks the path to developing and enabling LSD-based therapies to address patients with diverse health disorders.
MindMed is funding the launch of a clinical training program at NYU Langone Health that aims to facilitate the recruitment and training of more psychiatrists and clinical investigators in delivering psychedelic assisted therapies and psychedelic inspired medicines. In preparation for future deployment of these medicines, it is imperative to get psychedelic substances in front of clinical researchers and give them the resources they need to help clarify the path forward.
The NYU Langone Health Psychedelic Medicine Research Training Program will provide support, training, mentorship, and research funding necessary and will be managed by Principal Investigator Michael Bogenschutz, M.D., an expert in clinical trials research and the primary investigator leading the effort for approval of psilocybin-assisted psychotherapy for Alcohol Use Disorder by the FDA. The program will be directed by Stephen Ross, M.D., a world leader in advancing research on psychedelic medicine and a prominent addiction psychiatrist.
