- 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 The U.S. oral migraine drug market size is estimated to be $2.3 billion in 2025.2
- 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.
PALO ALTO, Calif., Dec. 26, 2023 (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 filed 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
"We are very excited about the potential of ELYXYB® since launching the product in the U.S. in April 2023. This is a highly complementary commercial asset that allows us to provide physicians with another tool in their pain management armamentarium to treat migraines earlier in the patient journey. We believe the filing of the NDS in Canada furthers our commitment to continue working towards redefining the role of opioids as a last resort rescue medication worldwide," said Jaisim Shah, Chief Executive Officer and President of Scilex.
For more information on ELYXYB®, including Full Prescribing Information, please visit ELYXYB.com
