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
The U.S. Food and Drug Administration (FDA) has granted priority review to Lykos Therapeutics’ new drug application (NDA) for the treatment of PTSD via MDMA-assisted therapy, with a target action date of August 11, 2024. Per the FDA, priority review status directs “overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.”
The application, submitted in December 2023, is reported to be the first NDA submission to the FDA for any psychedelic-assisted therapy. The protocol couples trauma-focused talk therapy, now the first-line treatment for PTSD, with the use of capsulated MDMA. While current PTSD treatments exhibit reasonable efficacy in lessening the severity of PTSD symptoms, many patients report limited improvement in functional abilities and overall quality of life. If approved, the protocol will not only be the first FDA-approved treatment of its kind but will also mark the first new FDA-approved drug treatment for PTSD in over 20-years.
“Much ink has been spilled over the decision to rebrand MAPS PBC as Lykos Therapeutics and their decision to raise funds from private investors, which to uninformed spectators is tantamount to selling out,” reflects Emerge attorney Matthew Brockmeier. “While everyone is entitled to their opinion, many are clearly missing the forest for the trees. When taken in context, along with the recent recommendation from FDA to DEA to reschedule cannabis, the drug war is ending in front of us. And everyone’s favorite (former) psychedelic nonprofit, MAPS, deserves much of the credit. For three decades, they were the lone wolf (pun always intended) in their crusade to compel the government to recognize the legitimacy of compounds that were for the majority of many of our lives mischaracterized as street drugs or party drugs. Of course we all want to see MDMA-assisted psychotherapy accessible and affordable for all. No one wants to see the psychedelic renaissance whitewash the legacy of plant medicines. And given the horrors of late-stage capitalism we are all currently experiencing, some healthy suspicion of for profit medicine is clearly warranted. But MAPS has never done business as usual, so let’s celebrate this victory with them.”
Other Noteworthy News
DEA Psilocybin Stance Critiqued by Federal Appeals Court
THE DALES REPORT – “A federal appeals court has criticized the DEA for not adequately explaining its refusal to reclassify psilocybin, highlighting a need for greater transparency in the drug scheduling process. This legal challenge, led by Dr. Sunil Aggarwal and the AIMS Institute, focuses on using psilocybin for palliative care in terminally ill cancer patients. [The DEA’s refusal] marks a significant moment in the ongoing debate over the scheduling of this substance under the Controlled Substances Act (CSA). [Reclassification] would acknowledge [psilocybin’s] potential medical use and lower restrictions on its research and application. The Ninth Circuit Court’s recent decisions have brought attention to the DEA’s process and rationale for denying these requests. The court found that the DEA failed to adequately explain its decision, highlighting a need for a more transparent and reasoned approach in evaluating petitions for rescheduling drugs with potential therapeutic value. This judicial critique opens a potential path forward for reconsidering how substances like psilocybin are classified and used within the medical community.”
Massachusetts Lawmakers Approve Psilocybin Bill to Legalize for ‘Therapeutic, Spiritual, and Medicinal Purposes’
MARIJUANA MOMENT – “With a psychedelics legalization initiative pending before lawmakers ahead of a potential vote on the November ballot, a Massachusetts legislative committee has advanced a separate bill that would legalize psilocybin therapy in the commonwealth and set up a framework to license facilitators who would supervise medical, therapeutic and spiritual applications of the drug. The measure, H.3605 from Rep. Nicholas A. Boldyga (R), would require the state Department of Public Health to establish a licensing process for both facilitators themselves and “independent training schools” to instruct them. Would-be facilitators would need to complete no less than 20 hours and no more than 300 hours of training from a licensed school, of which a minimum of 20 would need to be in-person practical training. Facilitators would also need to be 21 or older, Massachusetts residents, high-school graduates and free of felonies for the past five years prior to applying for a license. They would be allowed to possess up to five grams of psilocybin under the proposal. Participants 18 years or older, meanwhile, ‘may use psilocybin during facilitated sessions, by a properly licensed psilocybin facilitator, for therapeutic, spiritual and medicinal purposes,’ the bill says.
The measure advanced this week is one of three psychedelics reforms that sponsor Boldyga filed last year, including others to reschedule MDMA pending federal approval and set a price cap on therapeutic access. After activists collected an initial batch of signatures from voters, the legislature now has the choice of enacting the reform, proposing a substitute or declining to act entirely. If lawmakers decide not to legalize psychedelics by May 1, activists would then have until July 3 to submit at least 12,429 additional valid signatures to put the proposal before voters on the November 2024 ballot.”
The Interdisciplinary Annotated Psychedelic Research Bibliography of 2023
PSYCHEDELIC ALPHA – “Every year, [PsyAlpha] Medical Advisor, Michael Haichin chalks up a list of the psychedelics articles he deems most important or intriguing. As his annual list exceeded five hundred publications in 2023, he came up with an idea that would a) have the list see the light of day; and, b) collate the opinions of other psychedelics researchers on last year’s papers. As such, [PsyAlpha] is pleased to present the inaugural Interdisciplinary Annotated Psychedelic Research Bibliography. [Here], Michael presents the full list of publications, along with short comments from an interdisciplinary pool of researchers.”
Panel Approves Bill to Legalize Psychedelic Mushrooms for Mental Health Treatment
ARIZONA CAPITOL TIMES – “A republican senator’s attempt to pilot state legalization of psilocybin mushrooms as a treatment for mental health conditions got unanimous committee approval in the Health and Human Services Committee Tuesday [2/13/24]. Sen. T.J. Shope, R-Coolidge, introduced SB1570, which garnered support from veterans, physicians and mental health attorneys who underscored his effort as a positive progression in therapeutic options for those with previously untreatable mental illnesses. The bill would set up a Psilocybin Control and Regulation Fund administered by the Arizona Department of Health Services to provide grants for clinical trials. If passed, the legislation would permit DHS to begin receiving applications as soon as Jan. 2026 to administer licenses for psychedelic-assisted therapy centers. DHS employees who are initiating treatment would be exempt from prosecution for possession of psilocybin mushrooms.”
LISTEN: The Power of Psychedelic Therapy for Members of the Military
1A PODCAST (NPR) – “Many people hear the term “psychedelics” and think of hippies, acid, and the music of the 1960s. But it may soon take on a whole different meaning for the U.S. military.”
LISTEN: The Search for New Psychedelics
SCIENTIFIC AMERICAN – “As companies join the hunt, can the field of mind-altering synthetic substances stay true to its original pioneering spirit of wonder, curiosity and connection?”
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