Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119822
Chunk: 247

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 247
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5.4% vs. 1.8%, did not result in signs of systemic toxicity or increased application site reactions with daily applications over one month treatment. SP-103received FDA Fast Track status in LBP. We will continue to analyze the SP-103Phase 2 trial data along with an investigator study at Johns Hopkins University completed in the second half of 2023, investigating ZTlido in patients with chronic non-radicularneck pain, which also has shown promising top-lineefficacy and safety results. While the phase 2 trial in acute LBP had demonstrated an effect in a subpopulation of patients who had acute LBP associated with more severe muscle spasms, the investigator-initiated randomized, crossover, placebo-controlled trial showed substantial reduction of average daily pain in general population of patients with chronic non-radicularneck pain following the application of ZTlido. We therefore plan to prioritize further potential development of SP-103for the treatment of acute pain. SP-103,if approved, could become the first FDA-approvedlidocaine topical product for the treatment of acute pain. SP-104(4.5mg, low-dosenaltrexone hydrochloride delayed-release capsules) Two Phase 1 trials have been completed for SP-104at investigative sites in New Zealand:

| • |     | SP-104-01 is a food effect and                                                                                                                                                                                                                          
 bridging PK study comparing SP-104 to Naltrexone HCL Tablets conducted on approximately 18 healthy adult subjects. The study is designed to be an open-label, three-period, three-treatment, randomized study to                                        
 characterize the PK and safety and tolerability of SP-104 under fasting and fed conditions. Subjects are randomly administered a single dose of one of three treatments and followed for PK and safety for a                                            
 period of time followed by a washout period before receiving one of the other treatments. All subjects receive all three treatments. The study characterize the single-dose clinical studies and ultimately the commercial label. The study also serves 
 as a “pharmaceutical bridge” between SP-104 and the commercial RLD (Naltrexone HCI tablets, USP 50 mg) to support the eventual Section 505(b)(2) NDA. Assuming that the rate and extent of                                                              
 drug exposure for SP-104 will be lower than that observed for the RLD, this study allows us to rely upon the FDA’s findings of safety for the RLD instead of having to perform extensive nonclinical animal                                             
 safety toxicology