Scilex Announces Phase 3 SP-102 Results in PAIN Journal for Sciatica

The Phase 3 study results have been published in PAIN® Journal, a leading publication focused on pain medicine and research. PAIN is the official journal of the International Association for the Study of Pain, featuring original research on pain's nature, mechanisms, and treatment. This Phase 3 study achieved significant primary and key secondary endpoints, demonstrating that SP-102 (SEMDEXA™) treatment effectively reduced pain intensity for over a month in sciatica patients and resulted in significant and clinically meaningful improvements in the disability index score. Importantly, this was achieved while maintaining safety levels comparable to a placebo.

The topline data from this Phase 3 study was presented at the American Society of Interventional Pain (ASIPP) conference in Las Vegas in May 2022. The oral presentation was delivered by Dr. Nebojsa Nick Knezevic, a prominent figure in anesthesiology and pain management, affiliated with the University of Illinois at Chicago and various other prestigious positions.

The Phase 3 study signifies a potential breakthrough in treating patients with lumbosacral radicular pain (sciatica), who currently have limited therapy options. Existing treatments often involve off-label and suboptimal corticosteroid formulations, which can lead to excessive pain and disability. SP-102 (SEMDEXA™) received Fast Track status from the FDA in 2017, highlighting its potential importance.

Scilex Holding Company, based in Palo Alto, California, announced the publication of the pivotal registration trial results of SP-102 (SEMDEXA™) in PAIN. Scilex focuses on developing and commercializing non-opioid pain management products for acute and chronic pain treatment. SP-102 (SEMDEXA™) is a novel injectable corticosteroid gel for lumbosacral radicular pain, free from preservatives, surfactants, solvents, or particulates.

The C.L.E.A.R. Trial (Corticosteroid Lumbosacral Epidural Analgesia for Radiculopathy) aimed to examine the safety and analgesic effects of single and repeat transforaminal injections of SP-102 (SEMDEXA™) compared to a placebo. The trial involved 401 participants with low back pain due to unilateral intervertebral lumbar disc herniation, causing moderate to severe leg pain. This trial is the largest well-controlled study on epidural steroid injections for sciatica.

The study met its primary and key secondary endpoints with statistical significance, showing a considerable reduction in pain and improvement in disability and functional outcomes. The safety analysis revealed no significant safety risks, with no serious adverse events related to the drug or injection procedure. Adverse events typically associated with off-label steroid use, such as hematoma, infection, or paraplegia, were not observed. The trial also confirmed the safety of repeat injections, as participants experiencing moderate-to-severe radicular pain were allowed an additional open-label SP-102 (SEMDEXA™) injection. Safety was comparable across treatment groups through the 24-week study period.

Dr. Alan Miller, Principal Investigator from Coastal Clinical Research Specialists in Jacksonville, Florida, expressed optimism about the potential approval of SP-102 (SEMDEXA™) by the FDA. If approved, it would be the first corticosteroid approved for epidural injections, addressing current safety issues with unapproved steroid formulations.

Scilex Holding Company is committed to developing non-opioid pain management products and has several commercial products like ZTlido®, ELYXYB®, and Gloperba®. The company's product pipeline includes SP-102 (SEMDEXA™), SP-103 for chronic neck pain, and SP-104 for fibromyalgia, highlighting their ongoing efforts to address unmet medical needs in pain management.