Scilex Holding Company Provides Responses To Product Composition Questions Related To Its ELYXYB Patent In Canada For A New Drug Submission Under Review By Health Canada

Author: Happy Mohamed | March 18, 2024 09:04am

• 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
• The anticipated timeline for approval in Canada is approximately 12 months depending on review cycles and information requests by Health Canada. Scilex filed the NDS with Health Canada's Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences in December 2023

PALO ALTO, Calif., March 18, 2024 (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, today announced that it has responded to questions on the product composition in the ELYXYB patent from Health Canada's Office of Patented Medicines and Liaison (OPML) during review of a New Drug Submission ("NDS") to Health Canada's Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of ELYXYB® for 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

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