A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain

Authors

Alan Miller, Coastal Clinical Research Specialists, Fernandina Beach, FL, United States.
Kenneth D. Candido, Advocate Health - MidwestFollow
Nebojsa Nick Knezevic, Advocate Health - MidwestFollow
José Rivera, Tampa Pain Relief Center, Tampa, FL, United States.
Paul Lunseth, Clinical Research of West Florida, Inc, Tampa, FL, United States.
Dennis J. Levinson, Chicago Clinical Research Institute, Inc, Chicago, IL, United States.
Ferdinand Formoso, Coastal Clinical Research Specialists, Jacksonville, FL, United States.
Daneshvari Solanki, Hermann Drive Research Hospital, Bellaire, TX, United States.
Edward Tavel, Clinical Trials of South Carolina, Charleston, SC, United States.
Angela Krull, Physicians' Research Options, LLC, Draper, UT, United States.
Richard Radnovich, Injury Care Research, Boise, ID, United States.
Daniel Burkhead, Innovative Pain Care Center, Las Vegas, NV, United States.
Dmitri Souza, Western Reserve Hospital, Cuyahoga Falls, OH, United States.
Standiford Helm, The Helm Center for Pain Management, Laguna Hills, CA, United States.
Nathaniel Katz, WCG Analgesic Solutions, Wayland, MA, United States.
Robert H. Dworkin, Department of Anesthesiology and Perioperative Medicine, Research, University of Rochester School of Medicine and Dentistry, Rochester, NY, United States.
Steven P. Cohen, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, United States.
James P. Rathmell, Department of Anethesiology, Perioperative and Pain Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, MA, United States.
Asokumar Buvanendran, Department of Anesthesiology, Rush University, Chicago, IL, United States.
Joshua Levin, Departments of Orthopedic Surgery and Neurosurgery, Stanford University, Stanford, CA, United States.
Elizabeth Stannard, Clinical Development and Medical Affairs, Consultants to Scilex Holding Company, Palo Alto, CA, United States.
Chris Ambrose, Clinical Development, Scilex Holding Company, Palo Alto, CA, United States.
Mark Jaros, Summit Analytical LLC, Denver, CO, United States.
Kip Vought, Clinical Development and Medical Affairs, Consultants to Scilex Holding Company, Palo Alto, CA, United States.
Dmitri Lissin, Clinical Development, Scilex Holding Company, Palo Alto, CA, United States.

Recommended Citation

Miller A, Candido KD, Knezevic NN, et al. A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain. Pain. Published online June 14, 2024. doi:10.1097/j.pain.0000000000003287

Abstract

Epidural steroid injections are used to treat lumbosacral radicular pain. However, there are no Food and Drug Administration–approved corticosteroids for lumbosacral radicular pain and all currently available injectable corticosteroids carry safety warnings about their use in epidural steroid injection procedures. SP-102 (dexamethasone injectable viscous gel) was developed to provide a safer option with extended local effect. In a randomized, double-blind, placebo-controlled, multicenter trial, 401 patients with moderate-to-severe leg pain from unilateral intervertebral lumbar disc herniation were randomized (1:1) to receive transforaminal SP-102 or sham intramuscular (IM) placebo injection and followed for 24 weeks. If clinically warranted, a repeat open-label SP-102 injection was allowed between 4 and 20 weeks for both groups. Primary and key secondary end points were change in average daily pain on the Numeric Pain Rating Scale in the affected leg and disability measured by Oswestry Disability Index over 4 weeks. Other secondary end points included time to repeat injection, pain, and quality of life assessments. Over 4 weeks, SP-102 demonstrated statistically significant pain relief compared with placebo (least-squares mean group difference −0.52 [SE 0.163] [ P

= 0.002]) in the intent-to-treat population. Oswestry Disability Index mean improvement was −3.38 (1.388) (least-squares mean group difference [SE]) for SP-102 vs placebo ( P

= 0.015). Median time to repeat injection was 84 days for SP-102 vs 58 days for placebo ( P

= 0.001). Most other secondary end points were statistically significant for SP-102 compared with placebo. There were no serious adverse events related to study medication or procedure, no adverse events leading to death, and no AEs of special interest (paraplegia, hematoma, or infection).

Type

Article

PubMed ID

38875121