Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 257

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 257
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, although we believe the risk with this formulation has not been evaluated.

In addition to prescription lidocaine patches, there are commercially-available OTC topical lidocaine products in the market, but none of
these OTC products have been reviewed or approved by the FDA. Notably in 2003, the FDA proposed amending the tentative final monograph for OTC external analgesic drug products to clarify the status of patches (and poultices and plasters), noting
that the dosage forms had not been determined to be generally recognized as safe and effective for any analgesia at that time. Therefore, the FDA would likely not consider these OTC products to be compliant with the monograph and do not have legal
marketing status.

Our Solution

Our
novel adhesion and delivery technology provides significantly improved adhesion compared to Lidoderm, manufactured by Endo Pharmaceuticals, and generic alternatives marketed by Mylan N.V. (“Mylan”), while providing bioequivalent delivery
of lidocaine via an efficient drug delivery system. Our product is lighter, thinner and provides for a better patient experience without compromise to dermal safety and with no presentation of dermal sensitization. Below is a comparison of the key
advantages of ZTlido to Lidoderm and generic lidocaine patches manufactured by Teva and by Mylan.

172

Key Advantages of ZTlido vs. Lidoderm and Associated Generics Note: DIA = Drug-in-adhesive

| * | Source: A Scilex-sponsored              
 head-to-head comparative adhesion study 
 (SCI-LIDO-ADH-003)                      |

ZTlido has been strategically designed to address poor adhesion, a leading complaint associated with other currently marketed topical lidocaine products. ZTlido uses an advanced hot-melttechnology, which uses premixing and hot-meltmixing of various excipients and lidocaine, followed by cGMP compliant coating, lining, cutting and filling processes. In clinical studies, the technology provided significantly improved adhesion over Lidoderm ®(a branded, prescription 5% lidocaine patch product) (“Lidoderm”) and Mylan’s generic lidocaine patch at 12 hours after application. In a head-to-headstudy of 44 subjects, ZTlido showed statistically significant adhesion at all-timepoints compared to Lidoderm. Further, ZTlido maintained greater than 90% mean adhesion over the labeled 12