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Scilex Holding Company Announces Approval of a New Drug Submission (NDS) from the Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB®’s Acute Treatment of Migraine With or Without Aura ...
Scilex Holding Company Announces Approval of a New Drug Submission (NDS) from the Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology,
About this update from Scilex Holding Company
[{"type":"text","content":"Scilex Holding Company Announces Approval of a New Drug Submission (NDS) from the Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB®’s Acute Treatment of Migraine With or Without Aura in Canada \n ELYXYB® is a first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.1According to market data from 2018, it was found that migraine was more severe than other types of headaches and it impacted more than 2.7 million Canadians, with the Canadian migraine therapeutics market estimated to reach approximately $400 million by 2025.2 There is strong evidence for the use of non-steroidal anti-inflammatory drugs (NSAIDs) as a first-line treatment for migraine. ELYXYB® (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.3 PALO ALTO, Calif., April 15, 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, neurodegenerative and cardiometabolic disease, today announced that it has received approval of a New Drug Submission (NDS) from the Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB®’s acute treatment of migraine with or without aura in Canada. Clinicians in a recent market research study expressed their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use. ELYXYB®’s product profile mapped with a high degree of certainty to these stated unmet needs. In clinical studies, patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in approximately 50% of patients.4,5 “We welcome the approval of ELYXYB® (celecoxib oral solution) to the acute treatment options for nearly five million Canadians living with migr...