Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 244

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 244
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, single-application adhesion performance study in 44 healthy, human subjects to evaluate the adhesion performance of ZTlido compared to the adhesion performance of Lidoderm over a 12-hour administration period.

In this study, ZTlido demonstrated significantly superior mean adhesion
scores compared to Lidoderm at 3, 5, 9 and 12 hours after application. ZTlido maintained a mean percent adhesion performance greater than 90% over the 12-hour administration period, while Lidoderm fell
below 90% mean adhesion within three hours.

156

ZTlido Demonstrated Superior Adhesion Compared to Lidoderm

Head-to-HeadAdhesion Study versus Mylan’s Generic — SCI-LIDO-ADH-003

We conducted an open-label, single-treatment, two-period, single-application adhesion performance study
in 24 healthy, human subjects to evaluate the adhesion performance of ZTlido compared to the adhesion performance of a generic lidocaine patch 5% manufactured by Mylan over a 12-hour administration period. The
purpose of this study was to compare the adhesion performance of ZTlido against a topical lidocaine product involving a non-aqueous formulation. We selected Mylan’s generic lidocaine patch as a comparator
because it has similar product characteristics, including a non-aqueous polymer drug-in-adhesive system allowing for a thinner
patch and a lower drug load as compared to Lidoderm.

In this study, ZTlido demonstrated significantly superior adhesion performance
compared to Mylan’s generic lidocaine patch. ZTlido maintained a mean adhesion greater than 90% over the 12-hour administration period, while the generic product had a mean adhesion score of only 80%
immediately after application, which declined to a mean adhesion score of 27% at 12 hours after application.

157

ZTlido Demonstrated Superior Adhesion Compared to Mylan’s Generic Lidocaine Patch PK and Adhesion Study under Exercise and Heat Conditions— SCI-LIDO-HEX-001 We conducted an open-label, randomized, three-treatment, three-sequence, three-period, cross-over, PK and adhesion performance study of three ZTlido topical systems applied to separate areas in 12 healthy, human subjects during physical exercise, exposure to heat and under normal conditions, respectively. The three treatment periods were as follows:

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