PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.
Emerge’s Hot Take
FDA Gives an Early Nod to Psychedelic Research
On Thursday, Sept. 5, the FDA approved Mindstate Design Labs’ (MDL’s) plans for an early-stage clinical trial of 5-MeO-MiPT’s potential to treat depression, anxiety, PTSD, and other mental health conditions. Trials on the compound, otherwise known as “moxy,” are expected to begin this year at the Center for Human Drug Research in the Netherlands. Despite the FDA’s recent rejection of MDMA for PTSD treatment, many proponents of psychedelic-assisted therapies remain optimistic, and MDL has raised over $11M to date. The initial trials involve scanning the brains of 52 participants to study the effects of the drug and will primarily focus on assessing the compound’s safety. If the initial trials are successful, MDL will then move forward with late-stage trials that are crucial for FDA approval.
“It’s fairly encouraging to see this approval following last month’s rejection of proposed MDMA-assisted therapies,” says Emerge Law Group shareholder Alex Berger. “The MDMA decision was extremely disappointing and stoked concerns that FDA might reject all proposed psychedelic-assisted therapies. The approval of MDL’s early-stage trials at least indicates that FDA will entertain some types of psychedelic therapies. Because the approved MDL trial is designed to assess the safety of the treatment, I’m hopeful that researchers will use the approved MDL trial as a model for follow up MDMA trial and other psychedelic therapy trial applications.”
Other Noteworthy News
Colorado’s “First Psychedelic Church” for Magic Mushrooms Opens in Colorado Springs
THE COLORADO SUN – Benji Dezaval, a former mental health worker, runs The Community of PACK Life (CPL) from his home in Colorado Springs. Unofficially deemed “Colorado’s first psychedelic church,” CPL offers gatherings where people engage in discussions about community, pride, love, and social justice, and are offered small amounts of free psychedelics such as psilocybin and DMT. CPL is part of a broader trend following Colorado’s decriminalization of psilocybin in 2022, and while Dezaval hopes to register the church as a religious nonprofit, he doesn’t charge for the psychedelics or events, relying instead on donations. Per Dezaval, these gatherings aim to foster healing and wellness and to provide an inclusive space, particularly for those in the LGBTQ+ and neurodivergent communities, to explore the benefits of psychedelics and find a supportive environment.
A New Portland Shroom Service Center Offers Halloween Trips and Bargain-Priced Psychedelic Stock
WILLAMETTE WEEK – The Sacred Mushroom, a new psilocybin service center led by facilitator Bryan Arnold, opened recently in Portland’s Old Town. Notably, the center is the first publicly owned service center in the U.S., allowing investors to purchase penny stocks in the business. The center aims to attract visitors not only for privately facilitated sessions (with an estimated session cost of $1200-$1400 per person), but also for various events including corporate retreats and parties. The Sacred Mushroom is owned by Kaya Holdings, Inc, and marks the holdings company’s pivot from cannabis to psilocybin services. Despite ongoing concerns over high regulatory costs and competition from underground providers, the company is optimistic for the long-term economy of psilocybin and plans to expand operations to Colorado soon.
THE TUFTS DAILY – This summer, the Somerville City Council endorsed a Massachusetts proposition for the November ballot that would regulate psychedelics for supervised use in licensed service centers. The “Natural Psychedelics Substances Act” aims to provide safe access to psychedelics, reducing reliance on the underground market. Critics of the measure worry that the proposed legislation may make treatments unaffordable, and some also expressed concern regarding governance details. However, proponents argue that the Act is an important step towards wider legalization, and a strong sign of progress in decriminalization and legalization efforts.
Dr. Bronner’s Gives $50,000 to Psilocybin Treatment Center in Central Oregon
WILLAMETTE WEEK – Dr. Bronner’s, a California-based soap company known for its eco-friendly products and advocacy, recently donated $50K to Bendable Therapy, a nonprofit psilocybin service center in Central Oregon. Dr. Bronner’s has a long history of support for psychedelic therapy, having donated over $23 million to related advocacy and research over the past decade, and Bendable Therapy offers accessible psilocybin treatment by pairing clients with licensed guides. A major aim of Bendable Therapy is to remove economic barriers to treatment, towards which the organization has developed a scholarship model and awarded $230K to date.
NEW ENGLAND JOURNAL OF MEDICINE (interview) – How should the FDA evaluate psychedelic medicine? Executive Managing Editor Stephen Morrissey interviews Mason Marks, a professor at the Florida State University College of Law and the senior fellow and project lead of the Project on Psychedelics Law and Regulation at the Petrie–Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
LISTEN: A Scientist Took a Psychedelic Drug – and Watched His Own Brain ‘Fall Apart’
NPR HEALTH NEWS – Dr. Nico Dosenbach, an Associate Professor of Neurology at Washington University School of Medicine in St. Louis, relates his experience as part of a study designed to show how psilocybin produces its mind-altering effects.
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