Scilex Holding Company Begins GLOPERBA® Stocking Nationwide

13 June 2024

Scilex Holding Company (Nasdaq: SCLX), headquartered in Palo Alto, California, has announced the commencement of stocking for its latest commercial product, GLOPERBA®. This product is set to be available through all wholesalers with whom Scilex has established stocking arrangements throughout the United States, with an expected completion date of June 12, 2024. GLOPERBA® marks the third commercial product launch by Scilex, a company noted for its focus on developing and marketing non-opioid pain management solutions.

GLOPERBA® distinguishes itself as the first and only liquid oral formulation of the anti-gout medication colchicine, specifically designed for the prophylaxis of painful gout flares in adults. This FDA-approved treatment aims to provide an innovative solution for those suffering from gout, a condition characterized by sudden and severe attacks of pain, swelling, and redness in the joints.

Scilex’s initiative includes a comprehensive support system for patients, featuring a co-pay savings card to help offset treatment costs, thereby enhancing accessibility and adherence to the medication regimen. The introduction of GLOPERBA® into the market underscores Scilex’s commitment to expanding its portfolio of non-opioid therapies designed to meet the substantial needs of patients experiencing acute and chronic pain.

In addition to GLOPERBA®, Scilex’s portfolio includes several other notable products. ZTlido® (lidocaine topical system) 1.8% is a topical prescription product approved by the FDA for the relief of neuropathic pain associated with postherpetic neuralgia, a type of pain that follows shingles. Another significant product is ELYXYB®, an oral solution approved by the FDA for the acute treatment of migraine, with or without aura, in adults. ELYXYB® stands out as the only ready-to-use oral solution for this indication, potentially positioning it as a first-line treatment option for migraine sufferers.

Scilex is also advancing its pipeline with three product candidates at various stages of development. SEMDEXA™ (SP-102) is a novel, viscous gel formulation of dexamethasone sodium phosphate designed for epidural injections to treat lumbosacral radicular pain, commonly known as sciatica. This candidate has completed a Phase 3 study and received Fast Track status from the FDA. SP-103, a next-generation, triple-strength formulation of ZTlido, targets chronic neck pain and has recently completed a Phase 2 trial for low back pain. It also holds Fast Track status from the FDA. Lastly, SP-104 is a low-dose delayed-release naltrexone hydrochloride capsule currently being developed for fibromyalgia, a condition characterized by widespread musculoskeletal pain. Phase 1 trials for SP-104 concluded in the second quarter of 2022.

Notably, Scilex emphasizes its strategic focus on addressing high unmet medical needs within the large market of non-opioid pain management therapies. The company's efforts are aimed at improving patient outcomes through innovative solutions that offer significant market potential.

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