Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 249

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 249
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 completed a Phase 3 study; (ii) SP-103, a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which we have completed a
Phase 2 trial in acute LBP; and (iii) SP-104, a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which
Phase 1 trials were completed. We believe our currently approved products and future product candidates, if approved by the FDA, could uniquely address what we believe are the significant unmet needs of the targeted populations and become the
preferred treatment option for their respective indications.

Our guiding principle has always been and remains a patient-first approach,
which drives our mission to meet the increasing global demand for more effective and safer non-opioid pain management solutions. Through rigorous research and development, we believe we are on the cusp of
establishing Scilex as the preeminent name in commercial non-opioid pain management, specifically targeting the unmet needs in both acute and chronic pain sectors with our innovative and leading therapies. We
believe that we have not only responded to the global demand for safer, more effective pain relief solutions, but also made substantial progress in demonstrating the rapid onset and enhanced safety of our products.

Our Products

We launched our
first commercial product, ZTlido (lidocaine topical system) 1.8% in October 2018. ZTlido possesses novel delivery and adhesion technology designed to address many of the limitations of
current prescription lidocaine patches by providing significantly improved adhesion and continuous pain relief throughout the 12-hour administration period. ZTlido is a single-layer, drug-in-adhesive topical delivery system comprised of an adhesive material containing 36 mg lidocaine, which is applied to a pliable nonwoven cloth backing and covered with a
polyethylene terephthalate film release liner. ZTlido is commercially manufactured for us by Oishi in Japan. We license the rights to ZTlido from and rely exclusively on Oishi and Itochu pursuant to the Product Development Agreement, and the
Commercial Supply Agreement. We have exclusive worldwide rights to Oishi’s proprietary formulation and manufacturing technologies except with respect to Japan. In 2024, there were more than 206 million prescription lidocaine patches sold
in the United States, according to Symphony Healthcare.

We launched our second commercial product, ELY