Core Insights - Scilex Holding Company announced a publication regarding GLOPERBA dosing adjustments in a peer-reviewed journal, emphasizing its focus on non-opioid pain management products for various conditions [1][5] Company Overview - Scilex Holding Company is dedicated to acquiring, developing, and commercializing non-opioid pain management products aimed at treating acute and chronic pain, neurodegenerative diseases, and cardiometabolic diseases [1][6] - The company’s commercial products include ZTlido, ELYXYB, and GLOPERBA, with GLOPERBA being the first and only liquid oral version of colchicine for gout flare prophylaxis [6][9] Product Details - GLOPERBA allows for precision dosing and is particularly beneficial for over 70% of gout patients who have comorbid conditions requiring dose adjustments [2][4] - The publication highlights the importance of precise dosing for patients with renal impairment, suggesting specific dosages of 0.48 mg for moderate and 0.3 mg for severe renal impairment to maintain therapeutic levels and enhance safety [4][5] Clinical Significance - The publication is expected to provide essential data to guide clinical dosing of colchicine in patients suffering from gout and chronic renal failure, addressing a significant clinical need [5]

Core Insights - Scilex Holding Company has received FDA approval for Orphan drug designation for colchicine to treat pericarditis, enhancing its portfolio in non-opioid pain management products [1][3]. Company Overview - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, with a commitment to improving patient outcomes [5][10]. - The company is headquartered in Palo Alto, California [9][11]. Product Portfolio - Scilex's commercial products include: - ZTlido (lidocaine topical system) 1.8% for neuropathic pain relief [5][7]. - ELYXYB, an oral solution for acute migraine treatment [5][7]. - Gloperba, the first liquid oral version of colchicine for gout flare prophylaxis [6][7]. - The company has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections targeting lumbosacral radicular pain, which has completed Phase 3 studies [8]. - SP-103, a next-generation lidocaine topical system for acute pain, recently completing Phase 2 trials [8]. - SP-104, a low-dose naltrexone hydrochloride for fibromyalgia treatment [8]. Regulatory Insights - The Orphan Drug Act allows the FDA to grant orphan designation to drugs intended for rare diseases, which can lead to seven years of market exclusivity upon first approval [3].