Eric Myers’ Post

Excerpt: "Chin was among 104 participants in the multi-site trial, which found that those suffering from moderate or severe PTSD who took MDMA, paired with psychotherapy sessions, were about twice as likely to recover from their trauma as those who took a placebo. The findings, published Sept. 13, 2023, in the journal Nature Medicine, demonstrate the illegal so-called party drug could be a powerful new tool in treating people with moderate-to-severe PTSD. The trial, which included a diverse pool of participants, validates an earlier Phase 3 study and is the final step in clinical drug testing. This puts MDMA, used in conjunction with therapy to treat PTSD, on track to be the first psychedelic to seek approval from the U.S. Food and Drug Administration. By the end of the 18-week trial period, 71.2% of the people in the MDMA-assisted therapy group no longer met the diagnostic criteria for PTSD, versus 47.6% of those in the therapy-plus-placebo group. MDMA produced no serious, adverse side effects."

Could MDMA become the first approved therapy for PTSD in over 20 years? 🌟🧠💊 👉Approximately 13 million people in the United States are affected by post-traumatic stress disorder (PTSD) annually 👉Currently SSRIs are the main treatment for PTSD (to address commonly-associated symptoms of depression and anxiety), but these drugs take a while to take effect, and response rates rarely exceed 60% 👉There is a pressing need for new PTSD treatments 👉With significant results seen in late-stage placebo-controlled trials including 200 people with moderate-to-severe PTSD, MDMA (midomafetamine, or ecstacy) could become the first psychedelic-assisted therapy available in the US 👉However, medical experts who advise the FDA are not convinced that MDMA is effective in PTSD and that risks outweigh benefits, reporting that there were issues around the way the trials were conducted and the safety of MDMA 👀 🔍🔍 Critically, ‘’functional unblinding’’ makes it nearly impossible to test treatments such as MDMA (which alters mood, cognition and produces other psychedelic effects like distorting time or sensations) – most trial participants (and investigators) in the placebo-controlled studies were able to figure out what treatment was being given, an issue which may have swayed trial results to be more positive than they actually were…📈🤔

Results On MDMA Therapy For PTSD Are ‘Encouraging,’ But It’s Not Yet Ready For Widespread Adoption, Study Says A new scientific review finds that five out of six studies into MDMA for post-traumatic stress disorder (PTSD) “provide evidence for the apparent safety and efficacy” of the therapy. But while authors called the results “encouraging,” they say more robust research is needed before MDMA-assisted therapy (MDMA-AT) sees widespread adoption over currently available forms of treatment. “Though important caveats should be noted, randomized clinical trials of MDMA-AT for PTSD to date broadly demonstrate the apparent efficacy and safety of the approach,” according to new review, which was published in the Journal of Psychedelic Studies. “Participants in full-dose MDMA treatment arms have shown statistically greater improvements on the primary outcome measure (CAPS) in 5/6 studies (83.3%).” What’s more, the report notes, Phase III trials have shown that effects are significant and long-lasting—”durable to a year post-intervention”—and that risks are relatively minor. https://lnkd.in/gixWA2FF?

TMS is a game-changer for treating depression, anxiety, PTSD, OCD, and more. Imagine the positive impact to our community if more individuals could access TMS sooner, avoiding years of trial and error with oral medications. At Axis and similar practices, we are committed to educating, informing, and providing TMS to patients seeking a new approach to mood disorder treatments. Witnessing the incredible transformations enabled by TMS is truly rewarding. From patients leading better lives to the ripple effect on families and communities, the power of TMS is undeniable. #TMS #MentalHealthAwareness

As strong believers in the power of psychedelic therapy, we have been closely following Lykos Therapeutics’ efforts to get MDMA-assisted therapy FDA-approved for post-traumatic stress disorder (PTSD). While the FDA announced on August 9, 2024, that it would not approve MDMA-Assisted Therapy at this time, we at Elument, along with many of the 13 million Americans who suffer PTSD are relieved that this is not the end of the road. There is still substantial hope that MDMA therapies will become available in the future. Why? The FDA’s decision was primarily based on the structure and execution of the clinical trials conducted by Lykos, rather than the medicine itself. Because of this, the FDA requested an additional Phase 3 Study to be conducted. Lykos is working with the FDA to ensure that their next application has the highest possibility of success.   The set-back from this study will delay the availability of this breakthrough therapy for those suffering from PTSD, but there are other options. While MDMA therapy studies are still underway, Ketamine-Assisted Therapy (KAP) has shown positive results for PTSD, along with a significant amount of other mental health and wellness outcomes With proven track records through formal studies as well as clients like you who have worked with us at Elument, we have witnessed the profound and transformative impacts that ketamine assisted therapy can have in people’s lives as well as its potential to shape our mental health care system by paving the way for the future approval of additional psychedelic therapy options like MDMA and psilocybin. The recognition of KAP by the National Network of Depression Centers as a viable treatment for depression, as well as the exceptional results experienced by individuals with treatment-resistant conditions, further validates our efforts.   Link for full post in the comments.

Psychotherapy and antidepressant drugs are effective treatments for PTSD, however, it can take 5+ weeks to provide benefits. For those who need rapid relief from severe PTSD symptoms, ketamine could be an effective bridge. In this episode of the Academic Minute, UConn School of Pharmacy prof C. Michael White discusses a meta-analysis he let that evaluates the use of ketamine in patients with severe PTSD https://lnkd.in/emnYThaE

The data is promising!!

“Reports of my death are greatly exaggerated” - Mark Twain / MDMA Therapy. Yesterday an FDA Advisory Committee voted against the approval of MDMA-Assisted Therapy. But that’s not the end of the road - far from it. 13 million Americans suffer from PTSD. Not just combat vets but people like you and me — in fact, I’ve been one of those Americans. FDA hasn’t approved any new treatments in 25 years, and study after study shows the last-gen treatments don’t work. With growing support for psychedelics from the VA and bipartisan Congressmen like Morgan Luttrell, Dan Crenshaw, and Ro Khanna, it's clear the need for new PTSD treatments is urgent and mission critical. Lykos’ trials show that MDMA-AT is the most effective treatment for PTSD, with 87% of patients reporting significant improvements in only 3 sessions. And despite recent headlines, I’m still confident that FDA will approve MDMA-AT in August. Why? 🚫 FDA is not required to follow the AdComm’s recommendation and ignored a similar “no” vote when approving aducanumab for Alzheimer’s in 2021 📈 FDA’s presentation was positive: They highlighted the urgent need for effective PTSD treatments, acknowledged the strong evidence for MDMA-AT, and outlined a Risk Evaluation and Mitigation Strategy (REMS) to ensure safety. 🤝 FDA’s consistent support: From helping MAPS develop the study protocol to granting Breakthrough Therapy Designation and Priority Review, the FDA has shown strong backing for MDMA-AT. At Mindbloom, our goal of becoming the #1 provider of MDMA-AT hasn’t changed. We're dedicated to making this groundbreaking therapy accessible as soon as possible.

FDA’s Looming Decision on MDMA for PTSD: A Tipping Point for Psychedelic Medicine https://lnkd.in/eu_hg5PH MindMed ( $MNMD), Compass Pathways ( $CMPS), and Cybin Inc ( $CYBN) #stockstowatch #stocksinnews #investors #daytrader #PrismMarketView #PrismMediaWire #PrismDigitalMedia

ICYMI an FDA advisory panel said the benefits of MDMA-Assisted Therapy for PTSD did not outweigh the risks of FDA approval. It's not final, but the FDA will ultimately say no, and will do so in resounding fashion. MDMA-AT will be available one day but there are a lot of things that need to get sorted out beforehand. Concerns about sexual abuse that occurred during the trials were serious and worthy of further study. The Phase III trial allowed for therapists to incorporate a variety of healing techniques ranging from holotropic breathwork, EMDR, and a variety of other forms of therapy. This greatly confounded the results. The fact that you can't blind a patient on medications with psychedelic properties is a more methodological concern. We will never be able to get to the gold standard of randomized double blinded placebo controlled trials on these medications. People given psychedelic medicines know they took a psychoactive drug. Placebos in these trials are a joke. If we are going to move forward then we will likely need to accept that. Nonetheless, I do believe that MDMA-AT will save lives. The evidence points quite positively towards its efficacy. Some people will live in misery and others will likely die waiting for this treatment. Physiologically MDMA is safe. It looks to one day be a game-changer. For now, it's time to ask what we could do better and try again. https://lnkd.in/gCpezYvD