Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 252

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 252
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        | 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 ≥30), 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-102in patients with sciatica. We conducted this study to characterize repeat dose PD with respect to hypothalamic-pituitary-adrenal suppression using plasma cortisol levels, white blood cell count and blood glucose levels. The study enrolled 19 subjects, of which 15 received repeat SP-102epidural injections four to eight weeks after the initial injection. Four of the subjects did not experience recurrent pain and thus did not require a repeat injection. The daily average, current and worst pain in the affected leg and back showed continuous reduction throughout the 28-dayobservation period for both treatments. Based on a preliminary review of the results, SP-102injections were generally well tolerated and there were no new unexpected adverse events observed. Mean Percentage Change in Sciatica-Related Leg Pain as Measured by NPRS 165

Phase 1 Trial of SP-102(SEMDEXA) Compared to Reference Listed Drug — ES-1504

We conducted an open-label,
single-arm, two-period, fixed sequential-dose study to evaluate the PK, PD and tolerability of SP-102 when administered by
epidural injection. SP-102 was compared to intravenous dexamethasone sodium phosphate injection in subjects with lumbosacral radiculopathy. There were 12 subjects enrolled in this study, all of whom received SP-102 followed by the intravenous dexamethasone sodium phosphate injection (Reference Listed Drug (“RLD”)) administered one month later. A RLD is an approved drug product to which new versions are
compared to show that they are bioequivalent. The purpose of this study was to establish the pharmaceutical bridge between SP-102 and the RLD.