Scilex Holding Company Announces that It Will Be Filing Today of a Supplemental New Drug Application with the FDA for ELYXYB® in Acute Pain Indication

Core Viewpoint - Scilex Holding Company is advancing its non-opioid pain management portfolio by filing a Supplemental New Drug Application (SNDA) for ELYXYB, a new formulation of celecoxib aimed at treating acute pain, which is expected to enhance its market position in opioid-sparing therapies [1][5]. Group 1: Product Development and Efficacy - ELYXYB is a new oral liquid formulation of celecoxib that demonstrates superior analgesic efficacy and safety compared to placebo in treating acute pain following dental surgery, with significant improvements in pain intensity and treatment satisfaction across multiple doses [2][4]. - The formulation utilizes a self-microemulsifying drug delivery system (SMEDDS), enhancing bioavailability and allowing for effective treatment of acute migraine, as recognized by the American Headache Society [4][6]. Group 2: Market Opportunity - The acute pain market in the U.S. was approximately $3 billion in 2021, with around 100 million cases of acute pain reported, highlighting a significant opportunity for non-opioid therapies like ELYXYB [6]. - Approximately 40 million Americans are prescribed opioids annually for acute pain management, indicating a substantial market for opioid-sparing alternatives [6]. Group 3: Company Strategy and Future Outlook - The company aims to broaden the ELYXYB label to include additional acute pain indications, positioning it as a cornerstone in opioid-sparing pain management regimens [5]. - Scilex is focused on addressing high unmet needs in pain management through innovative non-opioid therapies, with a commitment to improving patient outcomes [8].