Company: SCLXW
Filing Date: 2025-05-14
Form Type: 10-Q
Source: 0000950170-25-071517
Chunk: 2

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 10-Q
Item: Item 2
Chunk 2
---
 naltrexone hydrochloride formulation for treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. 

SEMDEXA has been granted fast track designation by the FDA and, if approved, could become the first FDA-approved alternative to off-label epidural steroid injections, which are administered over 12 million times annually in the United States. We have completed a pivotal Phase 3 study with final results received in March 2022, which results reflected achievement of primary and secondary endpoints. SP-103 has also been granted fast track designation by the