Scilex Holding Company announced the publication of results of the pivotal registration trial of SP-102 (SEMDEXA?) in PAIN, the official journal of the International Association for the Study of Pain, which features original research on the nature, mechanisms and treatment of pain. SP-102 (SEMDEXA?) is a novel injectable corticosteroid gel formulation product in development for the treatment of lumbosacral radicular pain, which contains no preservatives, surfactants, solvents, or particulates. The C.L.E.A.R. Trial (Corticosteroid Lumbosacral Epidural Analgesia for Radiculopathy) was designed to investigate safety and analgesic effects of a single and repeat transforaminal injections of SP-102 (SEMDEXA?) compared to placebo (saline injection).

The trial enrolled 401 low back pain subjects with unilateral intervertebral lumbar disc herniation, resulting in radicular pain symptoms of moderate to severe leg pain. It is the largest known randomized well-controlled trial in sciatica using epidural steroid injections. The trial met its primary and important key secondary endpoints with statistical significance, demonstrating clinically meaningful reduction of pain, improvement in disability and functional outcomes.

Safety analysis demonstrated a clean safety profile with no identified safety risks. There were no serious adverse events related to the drug or injection procedure, and no adverse events of special interest reported, such as hematoma and infection at the injection site, or paraplegia. By contrast, these events are associated with the off-label use of non-approved steroid preparations.

The C.L.E.A.R trial also established safety of repeat injections, as patients who experienced moderate-to-severe radicular pain between 4 and 23 weeks following initial injection were allowed to receive an open-label additional SP-102 (SEMDEXA?) injection. The safety analysis was comparable between treatment groups through 4, 12 and 24 weeks of the study period.