Lykos Therapeutics’ Post

As a dedicated therapist who has had the honor of co-treating four individuals through the FDA Expanded Access program for MDMA-assisted therapy (MDMA-AT), I am convinced of its potential to bring hope and healing to those struggling with treatment-resistant PTSD. I've witnessed its impact firsthand and remain optimistic that MDMA-AT could become a new standard of care for PTSD. As regulatory bodies consider the approval of treatments that combine medication and psychotherapy, it's crucial to explore how research can effectively address the challenge of blinding in studies involving psychedelics versus placebos. Above all else, it is vital to center patient safety through rigorous research, training standards, appropriate licensing and certification, and in my opinion, developing robust, integrative, and accessible treatment delivery systems. There are many aspects to ponder, and I welcome thoughtful discussions on this important topic.

The Psychopharmacologic Drugs Advisory Committee (PDAC), a group of independent experts which advises the FDA, yesterday recommended not to approve MDMA for PTSD. Several companies, including Lykos Therapeutics, are currently developing MDMA, for a range of mental health disorders, in this case, PTSD in veterans. In PDAC's opinion, MDMA combined with psychological intervention to treat PTSD in adults was not effective and the risks outweighed the benefits regarding the FDA's proposed risk evaluation and mitigation strategy (REMS). Although PDAC's guidance to the FDA is not binding, it typically follows it. This is the first psychedelics drug application to be submitted to the FDA for a mental health condition. Psychedelics biotech will be watching keenly at the FDA's decisions because the outcome will either be a game changer or a death knell for investment into the research space. In the US, ~13 million people live with PTSD, and existing treatments, including SSRIs, have been hit and miss. New treatment options are desperately needed. The decision date is Sunday 11th August 2024. Everything crossed for you Lykos Therapeutics 🤞🏾🤞🏾 #psychedelic #mdma #ptsd #lykostherapeutics #mapsbc #mentalhealth #mentalhealthconditions #fda

Drug shortages pose a significant challenge to the healthcare system, affecting patient care and treatment outcomes. The FDA plays a crucial role in managing and mitigating these shortages. This blog discusses the causes of drug shortages, the impact on healthcare, and how the FDA works to address and prevent them. Read more here: https://lnkd.in/e7nTTUCA

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Calling all provider and patients! It’s time to stand up for what’s right & make our voices heard to protect compounded therapies. We need your help. We need your voice. Visit the link below to learn more how you can help us stand up for what’s right! #protectpeptides

Oversimplified, 'shock-value' headlines don't contribute to the ultimate goal - ensuring patient access. You build a Rube Goldberg system and then get surprised when it takes resources to navigate. R&D is part of what it takes to run a biopharma but Phase III, IV -- pre/post launch is necessary. It takes a village to deal with the changes in the Inflation Reduction Act, 340B, Medicaid, etc. -- on top of what companies were already (regulatory, medical affairs, contracting, etc.). Headlines intended to "shock" are not helpful to the goal of patient access.

This new rule will have significant consequences for patient care. It will increase costs and decrease access to crucial diagnostic tests that physicians rely on to treat their patients. Many believe that this is an overreach by the FDA, using statutory authority they do not possess. This Final Rule will slow healthcare innovation and reduce access to care for our patients. Let's bring back the VALID Act and ensure that our patients receive the care they need. #VALIDAct #patientcare #innovation #FDA

Thanks Roche for hosting the LinkedIn Live event "The Promise of Digital Endpoints in Healthcare" last week! Are you curious about 🤔 🔍 What benefits do digital endpoints offer for clinical trials? 🔄 How do digital endpoints compare to traditional methods in terms of ease of use, convenience, and overall experience for patients? 🌐 What updates to expect regarding the status of digital endpoints at regulatory bodies such as EMA and FDA? The talk led by Jeffrey Statland, Michelle Rohrer, Paul Strijbos, and damien eggenspieler has the answers to your questions! Check out the replay of the event to learn more about digital endpoints and their potential in clinical trials! The link is in the comments below! 📺🔗 #DigitalEndpoints #DigitalHealth #DigitalMeasures

Gratitude to the FDA for Their Invaluable Insights at the Annual Conference! A big thank you to the FDA for their indispensable contribution to recent annual conference! The insights were absolutely essential in shaping discussions around regulatory frameworks, industry standards, and the future of healthcare. Their dedication to ensuring safety, efficacy, and innovation in the medical field is truly commendable. Looking forward for more such fruitful discussions in the future! #FDA #Healthcare #RegulatoryInsights

Did you know groundbreaking discoveries need to navigate a series of tests before becoming life-saving treatments? Our blog explores clinical trials and the importance of transparency and FDA oversight in ensuring safe and effective healthcare solutions for all. Read the complete story: https://lnkd.in/gY3NUj6D #ClinicalTrials #FDAoversight #HealthFutuNearSociety