SCILEX HOLDING COMPANY (Nasdaq: SCLX, “Scilex”), is dedicated to the development and commercialization of non-opioid pain management products. We are uncompromising in our focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life.
The company’s lead product ZTlido® (lidocaine topical system) 1.8%, is a marketed prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with Post-Herpetic Neuralgia (PHN), which is a form of post-shingles nerve pain. ZTlido® possesses novel delivery and adhesion technology designed to address many of the limitations of current prescription lidocaine patches by providing significantly improved adhesion and continuous pain relief throughout the 12-hour administration period. Click here for ZTLido’s Important Safety Information and US Prescribing Information.
We have acquired two FDA approved non-opioid pain products, GLOPERBA and ELYXYBTM, for the treatment of gout in adults and oral solution for the acute treatment of migraine, with or without aura, in adults. We launched ELYXYBTM in the U.S. in April 2023 and are planning to commercialize GLOPERBA in 2024.
Our three product candidates are (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM”), a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica and has received Fast Track Status from the FDA. Currently there is no FDA approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a Phase 2, next-generation, triple-strength formulation of ZTlido, for the treatment of low back pain (“LBP”) and has received Fast Track Status from the FDA; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. If these product candidates are approved by the FDA, we believe each of them could become the treatment option for their respective indications in the United States.
SCILEX is committed to harnessing the power of revolutionary delivery technologies designed to safely and effectively provide therapies to those who need them the most.
Scilex Pharmaceuticals and Semnur Pharmaceuticals are wholly-owned subsidiaries of Scilex Holding Company.