Company: SCLXW
Filing Date: 2025-08-04
Form Type: S-1
Source: 0001193125-25-172703
Chunk: 260

Company: Scilex Holding Co
Filing Date: 2025-08-04
Form: S-1
Chunk 260
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.91)P<0.001(1)7-point scale rating patient’s overall improvement. Patient change is rated from “very much improved”, “much improved”, “minimally improved”, “no change”, “minimally worse”, “much worse” or “very much worse”.(2)Logistic regression models with treatment (SP-102 or placebo), site, and Pain Catastrophizing Scale group (<30 or ≥30) as factors.CI: confidence interval; ITT: intent-to-treat (randomized population)Time to Repeat Injection – ITT PopulationSP-102N=202PlaceboN=199Number of patients with Repeat Injection of SP-102 (patients who received open-label SP-102 between 4 and 20 weeks after initial injection)134 (66.3%)152 (76.4%)Number of censored patients(1)68 (33.7%)47 (23.6%)Chi-SquareP=0.026Time (days) to Repeat InjectionN134 (66.3%)152 (76.4%)Mean (SD)67.0 (33.31)57.8 (31.69)Median57.543.0Min, Max27, 14326, 14825th quantile (95% CI)(2)45 (43, 57)36 (34, 40)50th quantile (95% CI)(2)84 (71, 100)58 (50, 69)75th quantile (95% CI)(2)143 (141, 143)126 (87, 146)Comparison to Placebo(3)0.68 (0.54, 0.86)(Hazard ratio [95% CI]):P=0.001(1)Censored patients are the following: (1) patients who do not receive a repeat injection of SP-102 and (2) patients who discontinued the study prior to Week 20 without receiving a repeat injection.(2)Quartiles are estimated using Kaplan-Meier estimation.(3)A Cox proportional hazards model was utilized to test the treatment difference while adjusting for site and Pain Catastrophizing Scale (<30 or ≥30).CI: confidence interval; ITT: intent-to-treat (randomized population); SD: standard deviation169
Responder Analysis (Change from Baseline in Mean NPRS, Average Daily Pain in Affected Leg) (1)– ITT Population

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