New York, New York — November 4, 2025 — Leads & Copy — The U.S. Food & Drug Administration (FDA) has scheduled a meeting in early December to discuss Mesoblast’s (Nasdaq:MESO; ASX:MSB) 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). The company is actively recruiting a 300-patient confirmatory Phase 3 trial across 40 sites in the US, with enrollment expected to be completed in the coming quarter.
Mesoblast Chief Executive Silviu Itescu said FDA has emphasized the importance of developing non opioid treatments for chronic pain, and the company looks forward to discussing plans for rexlemestrocel-L as an agent that may result in both amelioration of CLBP as well as opioid reduction or cessation.
Rexlemestrocel-L has received Regenerative Medicine Advanced Therapy (RMAT) designation for treatment of CLBP due to degenerative disc disease.
Contact:
Emma Neal
+1 603 545 4843
emma.neal@allisonworldwide.com
Source: Mesoblast Limited
