Scilex Holding, a Subsidiary of Sorrento, Has Received From FDA a sNDA Approval for ZTlido Label Expansion - Seite 2

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin ("RTX"), and ZTlido (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase 1B trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido was approved by the FDA on February 28, 2018. SP-102 is undergoing a Phase 3 pivotal trial for the treatment of lumbosacral radicular pain/sciatica.

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About Scilex Holding

Scilex Holding Company, a majority-owned subsidiary of Sorrento, is a commercial-stage, non-opioid pain management company focused on the development and commercialization of topical and injectable therapies. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe chronic pain. Scilex launched its first commercial product in October 2018 and is developing its late-stage pipeline, which includes a pivotal Phase 3 candidate and two Phase 2 candidates. Its commercial product, ZTlido (lidocaine topical system) 1.8%, or ZTlido, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain. Scilex’s three product candidates are SP-102 (10 mg, dexamethasone sodium phosphate viscous gel), or SEMDEXA, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica with FDA Fast Track status, SP-103 (lidocaine topical system) 5.4%, or SP-103, a Phase 2, next-generation, triple-strength formulation of ZTlido, for the treatment of low back pain, and SP-104, Delayed Burst Release Low Dose Naltrexone (DBR-LDN), for the treatment of chronic pain, fibromyalgia, and chronic post-COVID syndrome (“long haul COVID” or “long COVID”) in multiple Phase 2 programs planned to be initiated this year.