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 Thumbs Down to MDMA for Now, Demanding Further Research
On Friday, 8/9, the FDA released its decision to not approve MDMA-assisted therapy for PTSD, stirring ongoing debate in the psychedelic research community. Many in the field were optimistic when Lykos Therapeutics initially submitted their New Drug Application in Dec. 2023, pointing to promising Phase 3 trials showing that over 70% of participants no longer met PTSD criteria after MDMA treatment. Anticipation of approval lessened significantly in June, however, when the FDA’s advisory committee recommended against approval of MDMA-assisted therapy. Despite support from veterans, mental health professionals, and politicians, the FDA cited concerns about the quality of the research and overall safety and efficacy of the drug. Lykos says it plans to seek reconsideration of the decision. But this process will delay the therapy’s availability for years, at least.
While some experts view the FDA’s decision as overly cautious, fearing it could stifle innovation in psychedelic therapies, others believe that the rejection might prompt stronger competition and better research quality in the future. The ruling also highlights the broader policy and regulatory challenges facing the psychedelic industry, bringing to light concerns about data quality, clinical trial designs, and the influence of public pressure on regulatory decisions. Despite this setback, Lykos says it remains committed to pushing forward with further research and regulatory efforts. Meanwhile others have been suggesting that psilocybin may now be on track to gain approval ahead of MDMA.
Emerge Law Group shareholder Sean Clancy had this to say: “FDA’s decision is not a surprise, given the advisory committee’s prior recommendation against approval. But it certainly is a disappointment for Lykos and others wishing for MDMA to be legalized as mental health medicine. Many are speculating about FDA’s exact rationale. And although Lykos will ask FDA to reconsider, it’s safe to assume that Lykos probably needs to revisit its methods and protocols to craft a better case for MDMA’s approval as a medicine. That will be expensive and time consuming. As FDA’s conclusion reverberates around the world of psychedelics, I will be interested to see how this affects psychedelic operators outside of pathology-focused medical frameworks.”
Other Noteworthy News
Gov. Healy Signs HERO Act, Establishing Psychedelics Working Group for Massachusetts Veterans
BENZINGA – On Monday, 8/12, Massachusetts Governor Maura Healey signed the HERO Act into law, less than one week after the FDA’s rejection of MDMA-assisted therapy. The Act in part creates a working group to study the potential benefits of psychedelic therapies like psilocybin and MDMA for veterans with mental health issues. This group, led by the Executive Office of Veterans’ Services, will review research and expert opinions, with preliminary reports due by January 1, 2025. Passage of the initiative reflects growing interest in alternative treatments for PTSD, especially as some Massachusetts cities have already relaxed enforcement of laws against psychedelics.
New Psychedelics Medical Research Center Opening in Kingston, Ontario
CBC – A new medical psychedelics research center launched Wednesday (8/7) at Providence Care Hospital in Kingston, Ontario, in collaboration with Queen’s University. The Centre for Psychedelics Health and Research will focus on studying the effects of psychedelics like psilocybin, LSD, and ketamine on mental health and substance use disorders. The center aims to build a knowledge base, train healthcare professionals, and reduce stigma around psychedelics, with plans to explore the use of psychedelics in both chronic pain and palliative care.
Psychedelic Mushroom Edibles Could Soon be Legally Available in Oregon for the First Time
OREGON LIVE – Oregon’s legal psilocybin program has taken another step forward with the first license granted for manufacturing psilocybin edibles. Spiritus Oregon, the company receiving the license, aims to improve accessibility and dosing precision with its Horizon Edibles line by providing a consistent, easier-to-digest experience for users. While the initial offering consists of chocolates with ground mushrooms, the company plans to introduce psilocybin extract gummies once their extraction process is finalized.
LISTEN: UNM Researchers Are Studying Psychedelics to Treat Depression and Meth Addiction
KUNM UNIVERSITY SHOWCASE – This episode provides “updates on new studies around psychedelic-assisted therapy, and features the University of New Mexico’s (UNM) Dr. Larry Leeman, a professor in the Departments of Family and Community Medicine who also directs the Milagro Program, which helps people overcome addiction during pregnancy. Leeman is studying the use of MDMA in treating opioid use disorder among those who are pregnant. He is starting new studies on treating postpartum depression with a compound similar to psilocybin, [in addition to] a study to treat major depressive disorder with psilocybin’
“Also featured is Dr. Snehal Bhatt, chief of the Division of Addictions Psychiatry, to talk about psychedelic therapy. Bhatt is launching a study later this year to explore how ketamine can treat methamphetamine addiction.”
