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     249  0 Kommentare Scilex Holding Company Announces Seeking Approval from the FDA for Modification of the Gloperba Label to Provide Specific Dosing Guidance for Patients with Renal Impairment and Other Circumstances Where Dose Adjustment is Needed - Seite 2

    Scilex expects to launch Gloperba in the first half of 2024. Gloperba is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Approximately 70% of gout patients have chronic kidney disease stage 2 and many suffer from gastrointestinal sensitivity, necessitating a lower dose of colchicine than the standard 0.6 mg tablet or capsule3. Gloperba is the first and only liquid colchicine formulation that allows healthcare providers to prescribe precision dosing in these at-risk patient populations, and thereby help mitigate against severe toxicity in patients. Healthcare providers can now safely and effectively manage these patients at doses below 0.6 mg once or twice daily, which is the standard dose for prophylaxis. For patients who are treated at doses lower than 0.6 mg, the 150 ml bottle of Gloperba is expected to last longer than 30 days, delivering additional value to patients.

    For more information on Scilex Holding Company, refer to www.scilexholding.com

    For more information on Gloperba, including Full Prescribing Information, refer to www.gloperba.com.

    For more information on ELYXYB, including Full Prescribing Information, refer to www.elyxyb.com.

    For more information on ZTlido including Full Prescribing Information, refer to www.ztlido.com.

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    info@scilexholding.com

    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 targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba , the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, expected to launch in the first half of 2024.

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    Scilex Holding Company Announces Seeking Approval from the FDA for Modification of the Gloperba Label to Provide Specific Dosing Guidance for Patients with Renal Impairment and Other Circumstances Where Dose Adjustment is Needed - Seite 2 Seek approval from the FDA for the modification of the Gloperba label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as …

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