Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 276

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 276
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 to have a deleterious or catastrophic effect on topical system performance, either as a dose-dump (i.e., immediate and complete release of all drug from the product), or as reduced drug delivery (i.e., much lower systemic exposure). There was no significant effect on PK observed with exercise when compared to subjects under normal conditions. ZTlido Demonstrated Consistent* PK Performance under Exercise and Heat Conditions

| * | Defined as no clinically meaningful changes by meeting bioequivalence criteria |

Dermal Sensitization and Irritation Study - SCI-LIDO-DERM-001 We conducted a provocative dermal sensitization and irritation human clinical trial, also referred to as a repeat insult topical system test, intended to elicit the worst-case dermal safety of ZTlido by extended wearing of 187

the product over multiple days. In this trial, we compared the sensitization potential, and the overall irritation profiles of ZTlido and Lidoderm in 218 normal and healthy subjects. We used a 7-pointscale where a score of 0 indicated no irritation and a score of 7 was considered a strong reaction spreading beyond the application site. In this study, results showed that the adhesion quality of ZTlido did not compromise dermal safety. The study reported that ZTlido did not show potential for dermal sensitization and showed an overall benign irritation profile. Both ZTlido and Lidoderm had a mean irritation score well below 1, which is defined as barely perceptible erythema. This study allowed for the ZTlido label to adopt the same local tolerance language as labeled for Lidoderm. Photoallergy and Phototoxicity Studies - SCI-LIDO-PHOT0-001and SCI-LIDO-PHOTO-002 We conducted a 6-weekrandomized study, SCI-LIDO-PHOTO-001,to evaluate the potential of ZTlido and its comparator, Lidoderm, to induce a photoallergic skin reaction in 54 healthy volunteers. In this study, we observed that ZTlido was not photoallergic. We conducted a 4-day,randomized study, SCI-LIDO-PHOTO-002,to evaluate the irritation potential of ZTlido and its comparator, Lidoderm, when application to skin is followed by light exposure in 32 healthy volunteers, using a phototoxicity patch test. In this study, we observed that ZTlido was not phototoxic. Post-Approval Studies for