Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 265

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 265
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-102 was made optional at the investigator’s
discretion.

SP-103(lidocaine topical system) 5.4%

We are developing SP-103 to be a triple-strength, non-aqueous
lidocaine topical system for the treatment of acute pain. SP-103 leverages the same adhesive drug delivery formulation and manufacturing as ZTlido along with comparable backing material, perforated release
liner and container-closure system. The increase in drug load is offset by a corresponding decrease in the adhesive diluent.

Our Solution

Our triple-strength SP-103 is an investigational, non-aqueous
lidocaine topical system undergoing clinical development in acute pain. If approved, we believe that SP-103 could become the lidocaine topical product for

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acute pain indications. This program builds on the learning from ZTlido because both products share the same superior adhesion and superior drug delivery formulation and manufacturing technology.
We are developing SP-103 to deliver a dose of lidocaine that is at least three times higher than any approved lidocaine topical products (including the approved ZTlido, which has a drug load of 36 mg
lidocaine). We manufacture SP-103 to have a drug load of 108 mg lidocaine in a similar superior adhesion as ZTlido, along with comparable backing material, perforated release liner and container-closure
system.

SP-103 has demonstrated delivery of three times the level of drug of ZTlido, and
consequently delivers three times the level of drug of Lidoderm and associated generics by extrapolation. SP-103 has been granted fast track designation by the FDA in LBP. We believe SP-103, if successfully developed and approved, may be able to address the limitations of prescription lidocaine patches in treating acute pain by delivering a higher dose of lidocaine to the application site, but
with systemic exposure of the drug remaining well below established safety thresholds. SP-103 has three times the drug load of ZTlido (108 mg versus 36 mg) in the adhesive system and can potentially deliver
three times the level of the drug within a targeted area, with the convenience of a single topical system. This level of dosage for SP-103 is comparable to the maximum approved daily dosage of ZTlido, or three
topical systems for up to 12 hours during a 24-hour period. By contrast, delivering higher levels of drug with other