Company: SCLXW
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047800
Chunk: 409

Company: Scilex Holding Co
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 409
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 . . . . . .  
    -1.56 (1.952)
    -0.98 (1.928)
    -0.59 (0.200)
    -0.98, -0.20
    0.003

 25

    Brief Pain Inventory – Short Form score (pain interference)(3) . . . . . . . . . . . . . .  
    -1.16 (2.413)
    -0.71 (2.095)
    -0.44 (0.221)
    -0.87, 0.00
    0.049

(1)	Baseline NPRS score is the mean of at least five days and no more than seven days of scores from the screening visit until treatment randomization. For the current pain, baseline is the last score prior to treatment. Baseline ODI is defined as the last ODI assessment score prior to the first dose on Day 1.

(2)	The analysis uses a REML-based MMRM with fixed effects for treatment (SP-102 or placebo), week, site, Pain Catastrophizing Scale group (<30 or ³30), baseline score, and treatment-by-week interaction.

(3)	The analysis uses an ANCOVA model with fixed effects for treatment (SP-102 or placebo), site, Pain Catastrophizing Scale group (<30 or ³30), and baseline score.

ANCOVA: analysis of covariance; ANOVA: analysis of variance; BPI-SF: Brief Pain Inventory – Short Form; 

CI: confidence interval; ITT: intent-to-treat (randomized population); LSM: least-squares mean; MMRM: mixed model for repeated measures; NPRS: numeric pain rating scale; REML: restricted maximum likelihood; SE: standard error

Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) – ITT Population

    SP-102 N=202
     
    PlaceboN=199

    PGIC Responders (number of patients who responded with “very much improved” or “much improved”(1)
    71 (35.1%)
     
    39 (19.6%)

    Chi-Square
    P<0.001

    Logistic regression (odds ratio [95% CI])(2)
    2.25 (1.42, 3.54)

    P