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Scilex Holding Company Announces the Completion of its SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido®, Phase 2 trial which achieved its objectives to Evaluate the Safety and Efficacy of SP-103 in Subjects with Moderate ...
Scilex Holding Company Announces the Completion of its SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido®, Phase 2 trial which
About this update from Scilex Holding Company
[{"type":"text","content":"Scilex Holding Company Announces the Completion of its SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido®, Phase 2 trial which achieved its objectives to Evaluate the Safety and Efficacy of SP-103 in Subjects with Moderate to Severe Acute Lower Back Pain (LBP) \n Scilex Holding Company announced completion of its SP-103 Phase 2 study to evaluate the safety and efficacy in subjects with acute LBP.The Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study evaluated the safety and efficacy of SP-103 (lidocaine topical system 5.4%) in subjects with moderate to severe acute LBP. The trial enrolled 75 patients at 10 sites across the U.S.SP-103 received Fast Track status from the FDA in September 2022.SP-103 is a pharmacologically validated drug candidate and has the potential as a leading agent for the treatment of LBP without the limitations of current therapies, including the addictive potential of opioids.An estimated 65 million adults in the U.S., or 25% of adults in the U.S., suffer from acute LBP1 with a total potential global market opportunity of approximately $10.0 billion by 2026 (Brand Essence Research 2020). PALO ALTO, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced the completion of its SP-103 Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy in subjects with acute LBP. Objectives of the trial were to assess safety and tolerability of SP-103 and to provide treatment effect estimates in patient population that can be used to power future studies. The trial enrolled 75 subjects, 38 received SP-103, and 37 received placebo. Topical systems were applied to the area of most tenderness in the lower back in 12-hours ON/ 12-hours OFF regimen. Preliminary analysis demonstrated the following results: No Serious Adverse Events (SAEs) or deaths observed.No Treatment Emergent Adverse Events (TEAEs) leading to early withdrawal.None of the subjects in the active group and 3 (8.1%) subjects in ...