Scilex Holding Company Announces Complete Enrollment of a Phase 2 Study to Evaluate the Safety and Efficacy of SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido®, for the Treatment of Acute Low Back Pain

• Scilex Holding Company, 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 complete enrollment of its SP-103 Phase 2 study to evaluate the safety and efficacy in subjects with acute low back pain. Top-line data from the Phase 2 study is expected in Q3-2023.
• The Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% in subjects with moderate to severe acute lower back pain (LBP). The trial is to enroll approximately 80 patients at 10 sites across the U.S. with acute LBP.
• 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).

Excerpt from the Press Release:

PALO ALTO, Calif., May 04, 2023 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX, “Scilex”), 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 complete enrollment in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% triple strength formulation for ZTlido®, in subjects with acute LBP.

“We are very pleased to have achieved this important milestone and would like to commend the experienced investigators and advisors of the SP-103 trial for their persistence and diligence in enrolling these patients. SP-103 has the potential to meet our core goal of developing leading pain management therapies to significantly improve the lives of patients with acute low back pain who are seeking new effective treatments,” said Jaisim Shah, Chief Executive Officer and President of Scilex.

“We are looking forward to analyzing the data and making further decisions regarding the potential Phase 3 program plans. We believe that Scilex is the only company with the technology allowing much higher lidocaine concentration than any other topical lidocaine treatments. Higher concentration of a drug per covered area of skin is important for achieving therapeutic response. We are very excited about the potential of SP-103,” said Dmitri Lissin, M.D., Chief Medical Officer of Scilex.

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