Scilex Holding Company Announces FDA Has Approved Our Request for the Orphan Drug Designation for Colchicine for the Treatment of Pericarditis

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].