Mesoblast is set to meet the FDA in December to discuss compelling Phase 3 data showing its cell therapy rexlemestrocel-L may significantly reduce opioid use in chronic low back pain patients. This meeting could mark a pivotal step in addressing the US opioid crisis through innovative regenerative medicine.
- FDA meeting scheduled for early December 2025
- Phase 3 trial shows over threefold increase in opioid cessation with rexlemestrocel-L
- Confirmatory 300-patient Phase 3 trial underway in the US
- Rexlemestrocel-L holds Regenerative Medicine Advanced Therapy (RMAT) designation
- Chronic low back pain linked to half of US prescription opioid use
Mesoblast’s FDA Engagement Signals Potential Breakthrough
Mesoblast Limited, a leader in allogeneic cellular therapies, announced that the U.S. Food & Drug Administration (FDA) has scheduled a meeting in early December 2025 to review data from its first Phase 3 trial of rexlemestrocel-L. This therapy targets chronic low back pain (CLBP) associated with degenerative disc disease, a condition that contributes significantly to opioid dependence in the United States.
The upcoming FDA discussion will focus on Mesoblast’s data demonstrating that patients treated with a single injection of rexlemestrocel-L combined with hyaluronic acid were over three times more likely to completely cease opioid use by 36 months compared to placebo. This finding is particularly notable given the ongoing opioid epidemic and the urgent need for effective non-opioid pain treatments.
Clinical Progress and Regulatory Advantages
Mesoblast is actively recruiting for a confirmatory Phase 3 trial involving 300 patients across 40 U.S. sites. This trial, designed in agreement with the FDA, aims to validate the initial positive results with a primary endpoint of pain reduction at 12 months. Secondary endpoints include improvements in quality of life and functional ability, with a special focus on opioid reduction.
Rexlemestrocel-L benefits from the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, which streamlines the regulatory pathway by offering rolling reviews and priority consideration. This status underscores the therapy’s potential to address a critical unmet medical need.
Addressing a Major Public Health Challenge
Chronic low back pain affects millions in the U.S. and is a leading cause of disability, particularly among adults under 45. It accounts for approximately half of all prescription opioid use, linking it directly to the opioid crisis. Mesoblast’s approach, leveraging off-the-shelf cellular medicines, aims to modulate inflammation and promote tissue repair, potentially offering durable pain relief without the risks associated with opioids.
CEO Silviu Itescu emphasized the importance of developing non-opioid therapies, highlighting the company’s commitment to advancing rexlemestrocel-L as a dual-action treatment that alleviates pain and supports opioid cessation.
Looking Ahead
While the FDA meeting represents a critical milestone, the path to approval still depends on the confirmatory trial’s outcomes and regulatory review. Mesoblast’s extensive intellectual property portfolio and manufacturing capabilities position it well to commercialize this therapy globally if approved.
Investors and observers will be watching closely as Mesoblast navigates this pivotal phase, with the potential to reshape chronic pain management and contribute meaningfully to combating opioid dependence.
Bottom Line?
Mesoblast’s upcoming FDA meeting could be a turning point for non-opioid chronic pain therapies amid a persistent opioid crisis.
Questions in the middle?
- Will the FDA accept opioid cessation as a key approval endpoint alongside pain reduction?
- How quickly can Mesoblast complete enrollment and report results from the confirmatory Phase 3 trial?
- What are the commercial and reimbursement prospects for rexlemestrocel-L if approved?