Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 269

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 269
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), major or progressive motor or sensory deficit, new-onsetbowel or bladder incontinence or urinary retention, loss of anal sphincter tone, saddle anesthesia, history of cancer metastatic to bone and suspected spinal infection. Without clinical signs of serious pathology, diagnostic imaging and laboratory testing often are not required. Although there are numerous treatments for nonspecific acute LBP, most have little evidence of benefit. Patient education and medications such as nonsteroidal anti-inflammatory drugs, acetaminophen and muscle relaxants are beneficial. SP-104(4.5mg, low-dosenaltrexone hydrochloride delayed-release capsules) We are developing SP-104for the treatment of fibromyalgia. Low-dosenaltrexone hydrochloride delayed-release capsules are routinely used off-labelto treat fibromyalgia and other chronic pain conditions such as complex regional pain. Fibromyalgia Market Overview Fibromyalgia affects an estimated 10 million people in the United States and an estimated 3% to 6% of the world population. While it is most prevalent in women, it also occurs in men and children of all ethnic groups. Fibromyalgia is the second most common disorder that rheumatologists encounter, seen in 15% of evaluated patients. Approximately 8% of patients cared for in primary care clinics have fibromyalgia. Prominent fibromyalgia researchers and specialists estimate the economic burden of fibromyalgia in the United States to be between $12 billion to $14 billion each year and the condition accounts for a loss of 1% to 2% of the national overall productivity. Potential Complications of Fibromyalgia The following is a non-exhaustivelist of complications of fibromyalgia:

| • |     | extreme allodynia with high levels of distress; |

| • |     | opioid or alcohol dependence; |

| • |     | marked functional impairment; |

| • |     | severe depression and anxiety; |

| • |     | obesity and physical deconditioning; and |

| • |     | metabolic syndrome. |

Although fibromyalgia is frequently grouped with arthritis-related conditions, there is no apparent inflammation or damage to the joints, muscles or other tissues. The diagnostic criteria for fibromyalgia are detailed in the chart below. 180

Currently approved products for pain in fibromyalgia, including duloxetine, pregabalin and milnacipran,
have limited efficacy. Responders applying such products can only demonstrate a