Fire Service Psychology Association- Admin’s Post

FDA's rejection of MDMA as a psychedelic-based treatment for mental health and PTSD has sparked discussions on the need for innovative therapies to address mental health challenges. Veteran organizations have long advocated for psychedelic-assisted treatments, emphasizing the potential benefits for those suffering from PTSD. Despite the setback, companies like Lykos Therapeutics are determined to appeal the decision and continue their efforts to provide new treatment options for individuals with PTSD. The FDA's call for additional research highlights the importance of ongoing innovation in psychedelic therapies and other treatment modalities for mental health conditions. #FDA #MDMA #psychedelictherapy #mentalhealth #PTSD #innovativetherapies #veteranorganizations #psychedelicassistedtreatments #LykosTherapeutics #newtreatmentoptions #FDAapproval #research #psychedelictherapies #mentalhealthconditions #appeal #treatmentmodalities #innovation #FDAresearch #PTSDtreatment #psychedelicmedicine #therapeuticoptions #mentalhealthsupport #psychedelicresearch #mentalwellness #therapyoptions #FDAdecision #psychedelicinnovation #mentalhealthawareness #traumatherapy #mentalhealthadvocacy

FDA Rejects MDMA Treatment for PTSD: Setbacks and New Directions Navigating the complex landscape of PTSD treatment, the recent FDA rejection of MDMA as a therapeutic option marks a significant development. While this may seem like a setback, it opens the door for new directions and innovations in the field. In our latest blog, we delve into: The reasons behind the FDA's decision Potential implications for ongoing research Alternative treatments and future possibilities This pivot challenges us to rethink our approach to PTSD treatment and underscores the need for continued research and advocacy. Dive into the full analysis to understand the nuances of this decision and what it means for the future of PTSD therapies. Read the full blog here: https://lnkd.in/e5w3DKDC #MentalHealth #PTSD #FDA #MDMA #MedicalResearch #HealthcareInnovation #WombleBondDickinson

The data is promising!!

There is a resurgence of research exploring the potential of psychedelics for hard-to-treat conditions such as depression, addiction, and anxiety.  MDMA (also known as ecstasy or molly) is known as an entactogen and is the first in a series of psychedelics under review by the FDA. On Tuesday, a federal advisory committee voted overwhelmingly against the use of MDMA. The novel treatment can potentially transform a field with significant need, but the committee had concerns about the integrity of the particular trials up for review. The Institute for Clinical and Economic Review recently commented that patients and providers in the trial treated psychedelics “more like a religious movement than like pharmaceutical products.” With limited information on patient recruitment, panel members raised legitimate some concerns :  -Many patients (40%) had prior experience with MDMA. -It has been reported that therapists may have influenced positive reporting. - Following allegations of sexual misconduct during an earlier trial there is concern for patient safety. Anything with the potential to heal has the potential to harm. The conversations around alternative medicine must start with potential side effects and warnings of adverse events. Rather than hide this information, let's learn from it and do better

Yesterday KittyHawk portfolio company, MAPS Public Benefit Corporation, a company dedicated to changing the way mental health conditions are treated, announced the submission of a new drug application (“NDA”) to the U.S. Food and Drug Administration for MDMA used in combination with psychological intervention. This investigational MDMA-assisted therapy is in development for individuals with post-traumatic stress disorder (“PTSD”) and if approved, would be the first psychedelic-assisted therapy approved for PTSD. “The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” said Amy Emerson, chief executive officer, MAPS PBC. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.” KittyHawk is honored and excited to be investors in MAPS' Series A. We think this will not only be an amazing investment, but a company that will help heal so many people. This should mean that the first psychedelic assisted therapy finally becomes legal sometime in 2024. You can find the press release at https://lnkd.in/dFcmwixV

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."

As leading federal advocates for Veterans’ access to MDMA-Assisted Therapy (MDMA-AT), we are deeply concerned by the FDA’s denial of Lykos’ NDA for MDMA-assisted therapy (MDMA-AT). This decision is not just a bureaucratic error; it is a significant setback for millions of Veterans struggling with PTSD across our nation. MDMA-AT is the most effective treatment ever developed for PTSD, a condition at the core of the Veteran suicide crisis that claims over 17 lives each day. The FDA’s decision is a missed opportunity to embrace groundbreaking science, save countless Veteran lives, and honor the sacrifices made by those who served our country. If this critical treatment remains inaccessible, we face losing an additional 6,000 Veterans to suicide this year alone—and every year thereafter. Healing Breakthrough and Heroic Hearts Project will not relent. Our commitment to advocating for this life-saving treatment is unequivocal. We will continue to push for progress, collaborate with stakeholders, and fight persistently until MDMA-AT is available to every Veteran who desperately needs and deserves it. We’ve come to expect at some point the government will make it a little easier to save our own lives but until then we will keep having these conversations and work in Oregon and take veterans overseas.

The FDA is considering approving MDMA for PTSD treatment, but a recent advisory panel vote throws a wrench in the plans. While some studies suggest MDMA could be a breakthrough treatment, the panel raised concerns about the research quality, safety risks, and potential bias. This could have a ripple effect on the entire field of psychedelic medicine, which is seeing a surge of interest for treating mental health conditions. Experts are divided, with some calling for further research and others urging caution. What does this mean for the future of psychedelics in medicine? Share your thoughts in the comments. #psychedelics #PTSD #FDA #mentalhealth

"Conclusions: This review did not find major benefits of cannabinoids in improving overall PTSD symptoms. Some benefits with regard to cluster B and E symptoms were observed. Some risks with regard to worsening suicidal ideation and violent behavior were also reported. Individuals with a comorbid CUD diagnosis may be at greater risk for negative cannabis-related PTSD outcomes. More experimental studies are needed to determine the causal effects of cannabis and cannabinoids in PTSD" #cannabis

Exciting Breakthrough in PTSD Treatment! Lykos Therapeutics, formerly MAPS Public Benefit Corporation, has reached a significant milestone as PLOS publishes the first study comparing the effects of investigational MDMA-assisted therapy and therapy with a placebo on emotional coping skills and self-experience in adults with severe PTSD. In their Phase 3 study (MAPP1), previously published in Nature Portfolio, results revealed a groundbreaking outcome. MDMA-assisted therapy demonstrated a statistically significant greater improvement in all self-experience measures, including self-compassion and being in touch with oneself, compared to therapy with a placebo. This breakthrough not only reinforces the potential of MDMA-assisted therapy but also opens new avenues for enhancing emotional coping skills in those battling severe PTSD. Kudos to the dedicated team at Lykos Therapeutics for advancing the frontier of mental health treatment! Lykos Therapeutics (formerly MAPS PBC) #PTSDTreatment #MDMAAssistedTherapy #MentalHealthBreakthrough #LykosTherapeutics