Scilex Announces Approval Of New Drug Submission From 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

• 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.1
• According 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 migraine. This unique option has proven efficacy and safety that can help patients achieve rapid pain freedom," said Dr. Christine Lay, Professor of Neurology and Founding Director of the Headache program at the University of Toronto.

"Canada is consistently among the top 10 global pharmaceutical markets. It is the second largest export destination for U.S. pharmaceuticals. It is also a strategic market for expansion globally, providing opportunities for increased international recognition and regulatory harmonization. We are very excited to expand the use of ELYXYB® to Canada, which is especially meaningful given the drug is manufactured in Canada, and to start helping Canadian patients who suffer from acute migraine," said Dmitri Lissin, MD, SVP and Chief Medical Officer of Scilex.