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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
ELYXYB®, a rapid onset and ready-to-use formulation of Celecoxib, delivers a first line non-opioid therapeutic alternative to habit-forming opioids and
About this update from Scilex Holding Company
[{"type":"text","content":"ELYXYB®, a rapid onset and ready-to-use formulation of Celecoxib, delivers a first line non-opioid therapeutic alternative to habit-forming opioids and acetaminophen, the leading cause of acute liver failure in the U.S.(1)DelveInsight estimates there were approximately 100 million cases of acute pain in the United States and that the total acute pain market in the U.S. was approximately $3 billion in 2021.(2)Approximately 40 million Americans with acute pain are prescribed an opioid to manage their discomfort each year.(3)ELYXYB® is the first and only ready to use oral solution designed to deliver fast and long-lasting migraine relief with the proven safety of COX-2 selectivity that is FDA-approved for the acute treatment of migraine, with or without aura, in adults.(4)Acute pain has been defined as \"the physiologic response and experience to noxious stimuli that can become pathologic, is normally sudden in onset, time limited, and motivates behaviors to avoid actual or potential tissue injuries.\"(1) Acute pain usually lasts for less than seven days but often extends up to 30 days; for some conditions, acute pain episodes may recur periodically. In some patients, acute pain persists to become chronic.(5) PALO ALTO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease, today announced that it will be filing today of a Supplemental New Drug Application (SNDA) with the FDA for ELYXYB® in acute pain indication. The analgesic efficacy and safety of ELYXYB®, a new oral liquid formulation of celecoxib with more rapid absorption than the capsule, were evaluated in the treatment of acute pain in adult patients after dental surgery. In this randomized, double-blind, placebo-controlled, dose-ranging study, 120 otherwise healthy adults who underwent the extraction of bilateral impacted mandibular third molar teeth and experienced moderate to severe pain post-surgery were randomly assigned to receive one dose of either placebo or ELYXYB®: 62.5, 125, or 250 mg. All 3 doses of ELYXYB® were signif...