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     365  0 Kommentare Scilex Holding Company to Present Data on ELYXYB (celecoxib oral solution) at the 65th Annual Scientific Meeting of the American Headache Society, in Austin, TX.

    PALO ALTO, Calif., June 16, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it will be presenting data on ELYXYB (celecoxib oral solution) for acute treatment of migraine with or without aura in adults at the 65th Annual Scientific Meeting of American Headache Society (AHS) to be held on June 14-18, 2023 in Austin, Texas.

    An industry-sponsored symposium entitled “ELYXYB: A Fast Acting Oral Solution for Acute Migraine” will be held on Friday, June 16, 2023 from 7:00AM – 7:45 AM CST. Stuart J. Tepper, MD, FAHS from Dartmouth-Hitchcock Medical Center will be presenting clinical trial data from the ELYXYB pivotal studies.

    A poster entitled “Detection and Adjustment for Participant Response Effects in a 2-Period, Randomized, Double-Blind, Placebo-Controlled Trial of Celecoxib Oral Solution for the Acute Treatment of Migraine” will be presented on Saturday, June 17 from 12:45 – 2:00 PM CST.

    About Scilex Holding Company

    Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex 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. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXATM, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex submitted a request to the FDA for a type C meeting for purposes of pre-NDA discussion with the FDA. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain.  Scilex launched its first commercial product ZTlido in October 2018, in-licensed a commercial product Gloperba in June 2022, and launched its third FDA-approved product ElyxybTM in April 2023. It is also developing its late-stage pipeline, which includes a pivotal Phase 3 candidate, and one Phase 2 and one Phase 1 candidate.  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 post-herpetic neuralgia, which is a form of post-shingles nerve pain.  Scilex in-licensed the exclusive right to commercialize Gloperba (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex in-licensed the exclusive rights to commercialize ElyxybTM (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. Scilex launched ElyxybTM in April 2023 and is planning to commercialize Gloperba in the fourth quarter of 2023 and is well-positioned to market and distribute those products. Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), 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%, a Phase 2 study, triple-strength formulation of ZTlido, for the treatment of acute low back pain, with FDA Fast Track status; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia that has completed multiple Phase 1 trial programs and is expected to initiate Phase 2 trials in 2023. For further information regarding the SP-102 Phase 3 efficacy trial, see NCT identifier NCT03372161 – Corticosteroid Lumbar Epidural Analgesia for Radiculopathy – Full Text View – ClinicalTrials.gov.

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    Scilex Holding Company to Present Data on ELYXYB (celecoxib oral solution) at the 65th Annual Scientific Meeting of the American Headache Society, in Austin, TX. PALO ALTO, Calif., June 16, 2023 (GLOBE NEWSWIRE) - Scilex Holding Company (Nasdaq: SCLX, “Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing …

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