Company: SCLXW
Filing Date: 2025-05-14
Form Type: 424B3
Source: 0001193125-25-119831
Chunk: 255

Company: Scilex Holding Co
Filing Date: 2025-05-14
Form: 424B3
Chunk 255
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-103was safe and well tolerated. Increase of lidocaine load in topical system by three times, compared with approved ZTlido, 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