Scilex Holding Company Announces that the U.S. FDA Has Acknowledged the Submission of Our Supplemental New Drug Application for ELYXYB® in Acute Pain Indication

Core Viewpoint - Scilex Holding Company has announced the acknowledgment of its Supplemental New Drug Application (SNDA) for ELYXYB by the U.S. FDA, targeting acute pain indications, which is a significant step in expanding its non-opioid pain management portfolio [1]. Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for both acute and chronic pain [3][4]. - The company is headquartered in Palo Alto, California [5]. Product Portfolio - Scilex's commercial products include: - ZTlido (lidocaine topical system) 1.8%, approved for neuropathic pain relief associated with postherpetic neuralgia [3]. - ELYXYB, the only FDA-approved ready-to-use oral solution for acute migraine treatment in adults [3]. - Gloperba, the first liquid oral version of colchicine for the prophylaxis of painful gout flares [3]. - The company has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections to treat lumbosacral radicular pain, which has completed a Phase 3 study [4]. - SP-103, a next-generation lidocaine topical system for acute pain, recently completed a Phase 2 trial [4]. - SP-104, a low-dose naltrexone hydrochloride for fibromyalgia treatment [4]. Strategic Initiatives - Scilex is forming a proposed joint venture with IPMC Company to develop treatments for neurodegenerative and cardiometabolic diseases, indicating a strategic expansion beyond pain management [1][3].