Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and Opioid Cessation
Mesoblast Limited - American Depositary Shares (MESO)
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Source: GlobeNewswire
NEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the U.S. Food & Drug Administration (FDA) has scheduled a meeting in early December to discuss Mesoblast's data on opioid reduction and cessation from its first Phase 3 study (MSB-DR003) of rexlemestrocel-L in patients with chronic low back pain (CLBP). In Mesoblast's first randomized controlled Phase 3 trial of 404 patients, 168 of whom were taking opioids at baseline, more than 3-fold higher numbers of patients treated with a single intra-discal injection of rexlemestrocel-L + HA were able to cease use of all opioids by 36 months compared with saline-treated controls (p=0.008). In light of the devastating opioid crisis that continues to rage in the US, in September 2025 FDA provided new Guidance to Industry on Development of Non-Opioid Agents for Treatment of Chronic Pain.1 Since CLBP is the principal
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