Scilex Holding Company Submits New Drug Application to Health Canada for Approval of ELYXYB® in the Acute Treatment of Migraine With or Without Aura

27 December 2023

Scilex Holding Company (Nasdaq: SCLX) is a company dedicated to acquiring, developing, and commercializing non-opioid pain management products for both acute and chronic pain. Today, the company announced the submission of a New Drug Submission (NDS) to Health Canada's Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy, and Neurological Sciences. The submission seeks approval for ELYXYB® for the acute treatment of migraines with or without aura in Canada.

Recent market research studies have indicated a need for fast and safe alternatives for two specific groups of acute migraine patients: those with an insufficient response to triptan therapy and those with contraindications to triptan use. ELYXYB® is positioned to address these unmet needs, as clinical studies have demonstrated that patients treated with ELYXYB® experienced pain relief in as little as 15 minutes. Additionally, about 50% of patients reported significant pain relief compared to a placebo within 45 minutes.

Jaisim Shah, Chief Executive Officer and President of Scilex, expressed excitement about ELYXYB®, emphasizing its potential as a valuable addition to physicians' pain management tools for treating migraines earlier in the patient journey. Shah highlighted the company's commitment to redefining the role of opioids as a last-resort rescue medication on a global scale.

 

Source: globenewswire.com