Psychedelic Medicine Coalition’s Post

While the FDA advisory committee identified many challenges associated with developing MDMA as a treatment for PTSD, “there will be other chances” for developing psychedelic-inspired medicines according to IPN Director David E. Olson. The advisory committee’s discussion reinforces the need for rigor in the design of clinical trials using psychedelics and highlights the importance of identifying next-generation compounds that solve some of the issues raised by the committee. While the path forward for MDMA treatment may be complex, the potential benefits for mental health are profound. Read this Science Magazine article for a more thorough dive into the FDA advisory committee’s discussion.   #psychedelictherapy 

In a recent webinar, Dr. Muneer Ali, Senior Director of Medical Affairs at Tempus, and Dr. Jon Durrani, a neurologist at Dayton Center for Neurological Disorders, discussed the value of using an evidence and guidelines-based approach to PGx reporting for personalized mental health treatment. If you missed the webinar, we shared our key learnings here: https://tempus.co/48U3cof

A great read, featuring insight from Dayton neurologist, Dr. Jon Durrani! “PGx helps clinicians to continuously consider the ramifications of gene-drug interactions, especially for patients suffering from other comorbidities.” #healthybrain #neuroscience #mentalhealth #pgx #tempus

It appears like psychedelics may not become available as a FDA-approved treatment option for patients with PTSD for now... Always sad to see those outcomes for groundbreaking ideas... Lessons for the industry that bears repeating: - Don't rely on the "there is nothing else available" trope to make it through regulatory approval": it is no substitute for clear clinical benefits in patients - Avoiding clear and transparent reporting of data, good and bad, for whatever reason may be attractive in the short term but can hurt very badly down the line - Avoid falling in love with ideas and the "mission": the rigorous conduct of clinical trials comes first to preserve their integrityù Cases like this are the exception rather than the rule, but those traps are still much too easy to fall for... - https://lnkd.in/g_DtaEnQ

A Breakthrough in Treating Anxiety: Single Dose of #LSD-Based Medicine Shows Remarkable Promise A groundbreaking study has revealed that a single dose of an #LSD-based medication could provide rapid and lasting relief for generalized #anxiety disorder (GAD), offering hope for novel treatments amidst the ongoing mental health crisis. At First Tracks, we are committed to advancing mental health care and sharing the latest research in treatment. We are excited to report the promising results from a phase 2B study of MM120 (lysergide d-tartrate), an investigational LSD-based medicine developed by MindMed. 🔹Rapid and Durable Response: A single oral dose of MM120 100 µg demonstrated rapid improvement in GAD, with 65% of patients experiencing a 50% reduction in anxiety and 48% achieving remission at 12 weeks. 🔹Broader Impact: Beyond anxiety, MM120 also led to significant improvements in depressive symptoms, indicating its potential for comprehensive mental health support. 🔹 Safety and Tolerability: The treatment was well-tolerated, with most adverse events being mild to moderate and transient, consistent with the expected effects. 🔹 Next Steps: With these encouraging results, a phase 3 study is on the horizon, moving us closer to new, effective treatments for GAD. We love following these groundbreaking advancements in mental health treatment and remain committed to integrating innovative, evidence-based solutions into #healthplans as they receive federal approval. Together, we can work towards a future where comprehensive, cutting-edge mental health care is accessible to all. https://lnkd.in/etZyQaXW #MentalHealthInnovation #EvidenceBasedTreatment #GADTreatment #LSDResearch #FirstTracks #MindMed #MentalHealthAwareness

MDMA for PTSD has been voted against (9 to 2) by the FDA's advisory committee. They say the risks outweigh the benefits and that the human trials are not impressive enough. FDA approval still is possible, as this is just "advice," but given past history, they tend to side with the advisory committee. Will be interesting to see what happens next. Any thoughts? https://lnkd.in/gr_JpJY5 #mdma #ecstasy #psychedelics #ptsd #mentalhealth #science #politics

Nice results from MindMed regarding topline outcomes from its Phase 2b clinical trial of MM-120 (#LSD) targeting generalized anxiety disorder (GAD). MM-120 met primary endpoint, showing statistically significant dose-dependent improvement in HAM-A scores four weeks post a single dose. As well, HAM-A reduction of 21.3 points, a 7.6-point improvement over placebo at Week 4. HAM-A is a standardized and widely used clinical tool designed to assess the severity of anxiety symptoms in individuals. It consists of a series of questions and observations that evaluate both psychological and physical manifestations of anxiety. With these results, MindMed anticipates that the study results will advance into Phase 3 clinical development for GAD. Yet another #psychedelic study making the leap to Phase 3 as results continue to shine in this industry. When will investors begin to notice?? https://thedalesreport.com/psychedelics/mindmeds-phase-2b-compound-mm-120-shows-promise-in-treating-generalized-anxiety-disorder/

It's world lab day during premenstrual disorders awareness month, when I can't help but celebrate the incredible work of our collaborating scientists, researchers, and innovators who make breakthroughs possible every day, and especially in the neglected field of premenstrual disorders. We are so excited to have had some recent research peer-reviewed and accepted for publication (results summarised here in the meantime: https://lnkd.in/eFMk-GpB) around the use of Nettle, our revolutionary menstrual neuromodulation therapy device for PMS and menstrual pain symptoms; and none of this would have been possible without amazing scientists who have paved the way for our work through their research, dedication and resilience, as well as utmost dedication to making a difference in women's (and AFAB individuals') lives. I'm mid-way through Shalene Gupta's new book on PMDD and other premenstrual disorders - and it is for people whose experiences were neglected for too long that every day of our research is made worthwhile. International Association For Premenstrual Disorders #PMDD #PMD #PMS #Womenshealth #Pain

Recently, the largest clinical trial to date investigating the potential use of MDMA in the treatment of PTSD was published in Nature Medicine. Again, the results were staggering: 71% of participants lost their PTSD-diagnosis after treatment (compared to 48% in the placebo-group). However, the problem with psychedelic trials is that it's really hard to keep participants blind to the treatment group they're in; it's quite easy to realize you got MDMA after you start obsessively clenching your jaw, for example. This means the trials can't really be placebo-controlled, because participants generally know whether they got a placebo or not, meaning the staggering results might be due to placebo effects. In the paper of this recent trial, the authors write that they think placebo effects played a minimal role in their results. The arguments they give to support that claim were... well, unconvincing. Michiel van Elk, Jacob Aday, and I wrote down why. Read the full Viewpoint in the PDF attached, or a short summary on my Twitter: https://lnkd.in/eCD64TuM

This prospective observational study at an Italian University Hospital assessed the long-term outcomes of 33 patients treated with VV-ECMO for severe respiratory failure, from January 2018 to May 2021. Follow-up evaluations at 6 and 12 months post-ICU discharge showed good cognitive and psychological outcomes, with improvements in PTSD symptoms, especially among COVID-19 survivors. #COVID19 #ECMO #LongTermOutcomes #QualityofLife