Scilex, a Sorrento Company, Announces Pivotal Phase 3 SP-102 (SEMDEXA™) Data Presentation At The American Society Of Interventional Pain (ASIPP) 2022 Annual Meeting
- SP-102 (SEMDEXATM) is the first non-opioid novel injectable corticosteroid gel formulation product in development for the treatment of lumbar radicular pain, and it contains no preservatives, surfactants, solvents, or particulates.
- The study met its primary endpoint with a highly statistically significant reduction in average daily leg pain in patients receiving SEMDEXATM compared to placebo (p<0.001).
- Data demonstrated the utility of SEMDEXA™ in rapidly reducing sciatica pain with an extended effect for up to 99 days following a single epidural injection of SP-102 (SEMDEXA™).
- 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. No adverse events of special interest such as hematoma and infection at the injection site, or paraplegia were reported. The C.L.E.A.R trial also established the safety of repeat injections, as patients who experienced moderate-to-severe radicular pain between 4 and 20 weeks were allowed to receive open-label additional SP-102 (SEMDEXA™) injection.
- The key secondary endpoint of Oswestry Disability Index, the gold standard for measuring degree of disability and estimating quality of life, showed a 28% improvement at 4 weeks on SP-102 (SEMDEXA™) compared to baseline (minimal clinically meaningful improvement 8%-12%).1 The LS Mean (SEM) difference as compared to placebo was -6.28 (1.49), with a p-value < 0.001.
- “It has been a while since new drugs have been developed for interventional pain procedures. We are anxiously awaiting a new injectable formulation of viscous gel dexamethasone with extended local effect and its FDA approval for the treatment of radicular pain based on the results of this large randomized multicenter placebo-controlled trial. If approved by the FDA, it will be the first corticosteroid ever approved for epidural injections addressing safety issues with steroid medications that have been used off-label in the past few decades. This could be an important addition to treatment options for these patients, a game-changer”, said Prof. Dr. Nebojsa Nick Knezevic, M.D., Ph.D.
Excerpt from the Press Release:
PALO ALTO, Calif., May 05, 2022 (GLOBE NEWSWIRE) — Scilex Holding Company (“Scilex”), a Sorrento Company (nearly 100% or over 99.9% majority-owned subsidiary of Sorrento Therapeutics, Inc.) (Nasdaq: SRNE, “Sorrento”) and a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, announced pivotal Phase 3 SEMDEXATM data presentation at the American Society of Interventional Pain 2022 annual meeting. The pivotal Phase 3 SP-102 (SEMDEXATM) trial has a highly positive results evaluating SEMDEXATM in sciatica patients following an epidural injection was presented at the Innovation summit session of the 2022 American Society of Interventional Pain (ASIPP) Annual Scientific Meeting in Las Vegas, Nevada. Results from this multicenter, randomized, double-blind, placebo-controlled study demonstrated that patients experienced rapid onset of pain reduction in sciatica pain and the effect lasted for up to 99 days following a single injection of SEMDEXATM at the end of the procedure. This is the first time this trial study data has been presented at a major North American medical meeting.
The podium presentation described the Phase 3 trial, known as the C.L.E.A.R. trial program, randomized 401 lumbosacral radicular pain/sciatica patients at 40 sites across 25 states in the U.S., which is the largest double-blind randomized controlled epidural steroid injection clinical trial in sciatica.
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