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
MAPS PBC Submits First NDA to FDA for Psychedelic-Assisted Therapy
The MAPS Public Benefit Corporation (MAPS PBC) announced on Tuesday that it has submitted a New Drug Application (NDA) to the FDA for the approval of MDMA assisted therapy in the treatment of PTSD. Per MAPS PBC, this is the first ever NDA submission to the FDA for any psychedelic-assisted therapy, and marks the culmination of 20+ years of clinical research by MAPS PBC’s parent non-profit, MAPS. The application consisted of results from two Phase III clinical trials. Both trials showed “improvement in functional impairment associated with PTSD” and “no serious adverse events were reported in the MDMA group in either study.” If approved, the proposed therapy would be the first of its kind to receive FDA approval and would necessitate DEA rescheduling of MDMA to make the drug available for prescription medical use. Proponents of the NDA express hope that FDA approval of an MDMA-assisted therapy will prompt greater investment in research and development of other psychedelic treatments and medicines as well as “provide encouragement to others in the field.”
”In 1986, when Rick Doblin founded MAPS in response to the federal government’s decidedly antiscientific prohibition of an obscure compound with unparalleled therapeutic potential called 3,4-Methylenedioxymethamphetamine (‘ecstasy’ or MDMA), people called him crazy,” observes Emerge attorney Matt Brockmeier. “Now, more than 37 years later, his critics are the ones who look a little foolish. But the almost inevitable approval and subsequent rescheduling of MDMA is just the beginning. Before its healing potential can be fully realized we still have to deal with thorny issues like drug labeling/off-label use, insurance/reimbursement, and the regulation of wrap-around support/psychotherapy. No question that this filing is cause for celebration, but there is much more work ahead.”
Other Noteworthy News
Congress Sends Biden Defense Bill That Would Fund Studies into Psychedelics Therapy for Active Duty Military
MARIJUANA MOMENT – “A large-scale defense bill that contains provisions to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members is officially heading to President Joe Biden’s desk. Days after bicameral negotiators announced they’d reached an agreement on the 2024 National Defense Authorization Act (NDAA), the Senate passed it on Wednesday and the House concurred on Thursday, sending it to the president. [T]he final deal maintained psychedelics research provisions championed by Rep. Morgan Luttrell (R-TX) that were attached to the House version over the summer. The adopted psychedelics section would require the Department of Defense (DOD) to establish a process by which service members with post-traumatic stress disorder (PTSD) or traumatic brain injury could participate in clinical trials involving psilocybin, MDMA, ibogaine and 5-MeO-DMT. The list of covered psychedelics was also expanded to broadly include ‘qualified plant-based alternative therapies.’ ‘I was honored to see several of my amendments and priorities accepted into the final version of the bill, including clinical trials on psychedelic therapy to treat PTSD, support for TBI research, and other key provisions that will ensure a safer, stronger United States,’ Luttrell said in a press release on Thursday. ‘This legislation will ensure America can face security challenges with lethality and readiness.’”
Do Psychedelics Have a Role in Psychiatric Treatment?
UCLA HEALTH – “UCLA Health psychiatrist Walter Dunn, MD, PhD shared [a recent study published in the New England Journal of Medicine]and other studies as he discussed the history, therapeutic potential and regulatory implications of psychedelic medicine during the 2023 Integrative Medicine Symposium presented by the David Geffen School of Medicine at UCLA. ‘There is tremendous excitement about the therapeutic potential of psychedelics,’ Dr. Dunn said, ‘both within the medical community and among the public. Federal funding agencies are also interested in psychedelics.’ The National Institutes of Health, The National Academies of Sciences, Engineering and Medicine and the U.S. Department of Health and Human Services have all held recent workshops on the topic. While there are several studies and lots of conversation going on, these treatments are not widely available, as the U.S. Food and Drug Administration (FDA) and medical governing bodies have yet to approve psychedelics for therapeutic use or issue guidelines for best practices. ‘It’s unclear,’ said Dr. Dunn, ‘whether the FDA will require a Risk Evaluation and Mitigation Strategy (REMS), and what that would entail, if these treatments are approved […] Right now, enforcement and regulation is primarily in the hands of the DEA.’”
Massachusetts Ballot Proposal Seeks to Legalize Psychedelics
DAILY WIRE – “Massachusetts voters may legalize certain psychedelics in 2024 through a ballot proposal awaiting final approval from their secretary of state. The proposed ballot question, the Natural Psychedelic Substances Act, would allow adults 21 and older to use and grow psilocybin and psilocyn, or the substances found in magic mushrooms, as well as the plant-derived psychedelics mescaline, ibogaine, and dimethyltryptamine (DMT). The proposal prohibits the retail sale of these psychedelics, with purchases only allowed at certain locations where the individual must use the drugs under the supervision of a licensed facilitator. If passed next November, the proposed law would take effect almost immediately: December 15, 2024. The state would catch up to the six Massachusetts cities that have already decriminalized magic mushrooms: Northampton, Easthampton, Amherst, Somerville, Cambridge, and Salem.”
WATCH: Exploring the World of Psychedelics in Wellness
CBS NEW YORK – ” A new series airing on CBS Mornings explores the world of psychedelics and alternative wellness.”
WATCH: Can New Psychedelic Drug Ibogaine Treat Opioid Addiction?
NBC TODAY – “A new psychedelic drug, ibogaine, has emerged as a potential solution for those battling with opioid addiction, with a 30% success rate. Though it’s not legal in the U.S. and there are documented heart risks associated with the treatment, advocates are pushing for more research and its legalization. NBC’s Katie Snow reports for TODAY.”
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