Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 243

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 243
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 |     | was able to be used under showering and bathing conditions in study SCI-LIDO-ADH-004; and |

| • |     | did not show clinically meaningful dermal irritation in study SCI-LIDO-DERM-001. |

ZTlido Study Details Pivotal Bioequivalence Study- SCI-LIDO-PK-002A We conducted a comparative single-dose PK study between ZTlido and Lidoderm designed as a two-waycross-over in 54 healthy subjects. In this trial design, each subject received a single dose of three ZTlido or three Lidoderm patches followed by a washout period and the administration of the other product. The purpose of this study was to establish bioequivalence between the products, which was determined by the statistical comparability of Cmax and AUC as shown in the figure below. This was considered the pivotal clinical trial for ZTlido, as it provided the pharmaceutical bridge between the two products and showed that ZTlido had comparable safety and efficacy to Lidoderm. As a result of successfully establishing the pharmaceutical bridge, no stand-alone clinical efficacy studies were required by the FDA to determine ZTlido’s analgesic effects for ZTlido’s approval. Mean Lidocaine Plasma Concentration Time Profiles — Semilog Scale Pivotal Adhesion Study— SCI-LIDO-ADH-001 We conducted an open-label, single-treatment, single-period, single-application adhesion performance study in 54 healthy, human subjects to assess the adhesion performance of ZTlido over the 12-houradministration period of the product. The study also investigated whether ZTlido met an FDA established adhesion performance benchmark of greater than or equal to 90% adhesion in greater than or equal to 90% of subjects in the study at the end of the administration period. At the end of the 12-houradministration period, over 90% of the subjects (49 out of the 54 subjects) maintained greater than or equal to 90% adhesion, with no adverse events reported during the study. 155

ZTlido Maintained Greater Than 90% Adhesion Over the 12-HourTime Period

This study was considered the pivotal adhesion study for marketing approval and is summarized in the
product label.

Head-to-HeadAdhesion Study versus Lidoderm— SCI-LIDO-ADH-002

We
conducted an open label, single-treatment, three-period