Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 275

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 275
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 generic product had a mean adhesion score of only 80% immediately after application, which declined to a mean adhesion score of 27% at 12 hours after application. ZTlido Demonstrated Superior Adhesion Compared to Mylan’s Generic Lidocaine Patch PK and Adhesion Study under Exercise and Heat Conditions - SCI-LIDO-HEX-001 We conducted an open-label, randomized, three-treatment, three-sequence, three-period, cross-over, PK and adhesion performance study of three ZTlido topical systems applied to separate areas in 12 healthy, human subjects during physical exercise, exposure to heat and under normal conditions, respectively. The three treatment periods were as follows:

| • |     | Treatment A sought to assess the PK and adhesion performance of ZTlido under physical exercise conditions. In 
 this treatment period, subjects were instructed to perform exercise for 30 minutes on a                       |

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| stationary bike achieving a heart rate of 108 beats per minute, with continuous heart monitoring during exercise. Subjects were instructed to perform exercise immediately after the application of 
 the topical system and at 2.5, 5.5 and 8.5 hours following the application of the topical system.                                                                                                   |

| • |     | Treatment B sought to assess the PK and adhesion performance of ZTlido under heat conditions. In this treatment                                                                                       
 period, a heating pad adjusted to the medium setting was applied for 20 minutes immediately after application of the topical system and at 8.5 hours following the application of the topical system. |

| • |     | Treatment C sought to assess the PK and adhesion performance of ZTlido under normal conditions. In this treatment 
 period, topical systems were applied to the mid-lower back and worn for 12 hours.                                 |

In treatment A, adhesion and PK performance were not compromised by exercise, as reflected in the product label. In treatment B, heat had an effect on PK but had no effect on adhesion. In Treatment C, normal PKs were observed and greater than 90% of subjects showed greater than 90% adhesion. No meaningful irritation was observed across all treatments across all time points in any of the subjects. The impact of heat and exercise on PK is presented in the figure below. It was observed that heat had an effect on Cmax, but the drug returned to normal levels after removal of heat and there was no clinically meaningful observed effect on AUC. Heat did not appear