Post by Mark J. Field

A new marketing authorization for a first-in-class non-opioid in chronic pain is a genuinely rare regulatory event - worth noting for anyone working in analgesic development. Congratulations to the VERTANICAL team as they have received marketing authorization in Germany for Exilby® (VER-01) in chronic low back pain with a radicular (neuropathic) component. ✅ The approval was supported by two pivotal randomized, controlled Phase 3 trials in over 1,200 patients ✅ VER-01 demonstrated significant pain reduction, a favorable tolerability profile, and no evidence of dependence ✅ In a head-to-head Phase 3 comparator study, Exilby® showed superior pain reduction and better gastrointestinal tolerability than opioids ✅ A pivotal U.S. Phase 3 trial is now underway under FDA Breakthrough Therapy Designation, with a first data read-out anticipated in 2027 💊 Exilby® is an investigational standardized full-spectrum extract derived from the Cannabis sativa strain DKJ127 L., a unique and proprietary plant genetics selected to provide a phytochemical profile tailored to chronic pain. Its composition includes a defined mixture of cannabinoids, terpenes and other bioactive compounds selected for their potential relevance in pain modulation and associated symptoms. Identifying the optimal responder population, like the chronic back pain subgroup Vertanical determined, is a principal determinant of clinical success. However, chronic pain is mechanistically heterogeneous, and current R&D approaches typically do not identify optimal patient groups which leads to the use of broad populations and high failure rates in clinical trials. Novel platforms like Pain Cloud® are aiming to change the game by using network biology to: ✅ Identify which disease phenotypes a research target actually modulates ✅ Map novel mechanisms to specific patient subpopulations ✅ Enable precision patient selection BEFORE Phase II/III trials 💡 Pain Cloud® is a novel digital platform (created by eptivA Therapeutics Ltd. and Infopoly Ltd) that uses a precision medicine approach to pain drug R&D. In contrast to traditional one-size-fits-all drug development, Pain Cloud harnesses advanced in-silico techniques and big data to guide the discovery of targeted pain treatments identifying the optimal patient groups from over 1000 conditions for research targets. Find out more at Pain Cloud® Vertanical Press Release: https://lnkd.in/eFBgqcEk #ChronicPain #NonOpioid #DrugDevelopment #PrecisionMedicine #PainCloud #Neuropathy