Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 217

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 217
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 We filed a New Drug Submission to Health Canada’s Pharmaceutical Drugs
Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of ELYXYB for acute treatment of migraine with or without aura in Canada.

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We launched our third commercial product, GLOPERBA, in June 2024. We acquired certain rights
to GLOPERBA and the exclusive license to use the trademark “GLOPERBA”, pursuant to the Romeg License Agreement we entered into with Romeg, dated as of June 14, 2022, which
agreement was subsequently amended on January 16, 2025. GLOPERBA is an FDA-approved, liquid, oral medication for the treatment of gout in adults. Gout is a painful arthritic disorder affecting an
estimated 9.2 million people in the United States. Gout pain can be excruciating and is a form of inflammatory arthritis that develops in some people who have high levels of uric acid in their blood. It can cause sudden severe episodes of pain
and can be disabling with tenderness, warmth and swelling. Non-steroidal anti-inflammatory drugs, colchicine and corticosteroids are used a majority of time as the first line to treat acute gout. The U.S. is
observed to have a high prevalence of gout, owing to lifestyle issues such as high alcohol intake, obesity, and smoking. We commercialized GLOPERBA in June 2024 and believe we are well positioned to market and distribute the product. We have a
direct distribution network to national and regional wholesalers and pharmacies throughout the U.S. For more information, please see the section titled “Business — Material Agreements — Romeg License and Commercialization Agreement.”

Our Product Candidates

We acquired SP-102 from Semnur in March 2019 and are developing
SP-102 to be an injectable viscous gel formulation of a widely used corticosteroid designed to address the serious risks posed by off-label ESI, which are administered
over 12 million times annually in the United States. SEMDEXA has been granted fast track designation by the FDA and, if approved, could become the only
FDA-approved ESI for the treatment of sciatica. According to a report by Decision Resources Group, it was estimated that over 4.8 million patients would suffer from sciatica in the United States in 2022.
We received our SP-103 Phase 2 top-line results