Mesoblast Ltd (NASDAQ:MESO, ASX:MSB) will meet with the FDA in early December to review data from its first Phase 3 study of rexlemestrocel-L showing reductions in opioid use among patients with chronic low back pain (CLBP).
In that randomised, controlled trial (n=404), 168 patients were on opioids at baseline. By 36 months, patients receiving a single intra-discal injection of rexlemestrocel-L plus HA were more than three times as likely to discontinue all opioids as those given saline.
“In light of the ongoing US opioid crisis, the FDA in September 2025 issued new Guidance to Industry on developing non-opioid treatments for chronic pain,” the company noted. “Because CLBP is a leading driver of chronic prescription opioid use, there is a clear need for a safe, effective, and durable opioid-sparing therapy for patients with CLBP associated with degenerative disc disease.”
Mesoblast is seeking FDA approval based on CLBP reduction through 12 months and is running a 300-patient, 40-site confirmatory Phase 3 study in the U.S., with enrollment expected to complete in the coming quarter.