Company: SCLXW
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047800
Chunk: 411

Company: Scilex Holding Co
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 411
---
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.

 26

(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 ³30).

CI: confidence interval; ITT: intent-to-treat (randomized population); SD: standard deviation

Responder Analysis (Change from Baseline in Mean NPRS, Average Daily Pain in Affected Leg)(1) – ITT Population

    SP-102 N=202
     
    PlaceboN=199

    30% reduction
    88 (43.6%)
     
    57 (28.6%)

    Chi-Square
    P=0.002

    Logistic regression(2) (odds ratio [95% CI])
    1.96 (1.28, 2.98) 

    P=0.002

    50% reduction
    58 (28.7%)
     
    41 (20.6%)

    Chi-Square
    P=0.060

    Logistic regression(2) (odds ratio [95% CI])
    1.58 (0.99, 2.52) 

    P=0.055

(1)          Patients that discontinued or have missing scores at Week Four were considered non-responders.

(2)          Logistic regression models with treatment (SP-102 or placebo), site, and Pain Catastrophizing Scale group (<30 or ³30), and baseline averaged daily pain score as factors were used to compare the treatment groups at each week.

CI: confidence interval; ITT: intent-to-treat (randomized population)

Phase 2 Repeat Dose Study - SP-102-03

We conducted an open-label, single-arm, pharmacodynamics (“PD”) and tolerability study of repeat epidural injections of SP-102 in patients with sciatica. We