Scilex Holding Company announced publication in Anesthesiology Journal of results from an investigator-initiated research study using ZTlido for the treatment of chronic neck pain. The study demonstrated a clinical benefit trend for ZTlido in treatment of neck pain, where 27.7% of patients experienced a positive outcome on ZTlido, versus 14.9% on placebo. The effect was more pronounced during the first study period, reaching statistical significance. Analysis of both treatment periods did not show significant results due to the carry-over effect of the crossover study design and less than anticipated sample size due to early termination of the study. A positive trend was also observed for corresponding neck disability index. Overall, separation between ZTlido and placebo effects and variability observed in this patient population provided necessary estimates for planning a potential Phase 3 development trial of SP-103, which contains 3-times higher concentration of lidocaine. Additionally, this study provided essential insight into selection of patient population responsive to topical lidocaine treatment. Application of ZTlido was well-tolerated and safety profile consistent with other ZTlido trials previously conducted by Scilex.
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