Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and Opioid Cessation

Core Insights - Mesoblast Limited announced a meeting with the FDA in early December to discuss data on opioid reduction and cessation from its Phase 3 study of rexlemestrocel-L for chronic low back pain [1][4] Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for inflammatory diseases, focusing on severe and life-threatening conditions [10][11] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 [14] Clinical Trial Details - The first Phase 3 trial involved 404 patients, with 168 on opioids at baseline; those treated with rexlemestrocel-L showed over 3-fold higher rates of opioid cessation compared to controls by 36 months (p=0.008) [2][6] - A confirmatory Phase 3 trial is actively enrolling 300 patients across 40 sites in the U.S., focusing on chronic low back pain due to degenerative disc disease [5][6] Regulatory Context - The FDA has emphasized the need for non-opioid treatments for chronic pain, with new guidance issued in September 2025 [3][4] - Rexlemestrocel-L has received Regenerative Medicine Advanced Therapy (RMAT) designation, allowing for benefits such as rolling review and priority review for its Biologics License Application [8] Market Need - Chronic low back pain affects over 7 million people in the U.S. and is a leading cause of disability, contributing to approximately 50% of prescription opioid usage [9][7]