- The company’s lead product ZTlido® (lidocaine topical system) 1.8%, is a 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.
- The latest addition to our non-opioid pain management portfolio is Elyxyb® (celecoxib oral solution) indicated for the acute treatment of migraine with or without aura in adults. Scilex is planning to continue the commercialization of Elyxyb® in 2024.
- GLOPERBA®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, is expected to launch in 2024. Scilex in-licensed the exclusive rights to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex is planning to commercialize Gloperba® in 2024 and is well-positioned to market and distribute the product.
- Scilex’s three product candidates are:
SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status. If approved by the FDA, the company expects SP-102 to be the first FDA-approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica, with the potential to replace 12 million off-label epidural steroid injections administered each year in the US.
SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain. We have recently completed a Phase 2 trial in acute low back with SP-103 and an investigator-initiated Phase 2 study in chronic neck pain with ZTlido that was published in Anesthesiology journal. SP-103 also received Fast Track status in low back pain from FDA.
SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia. - Scilex Holding Company is uncompromising in its 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.
- Scilex Pharmaceuticals and Semnur Pharmaceuticals are wholly-owned subsidiaries of Scilex Holding Company.
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