PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a firm engaged in developing non-opioid pain management therapies, has recently made progress with the Canadian regulatory process for its migraine medication, ELYXYB®. The company responded to Health Canada's Office of Patented Medicines and Liaison (OPML) inquiries regarding the product composition in ELYXYB's patent, as part of its New Drug Submission (NDS) review by Health Canada's Pharmaceutical Drugs Directorate.
ELYXYB, an oral solution for the acute treatment of migraines with or without aura in adults, is the only such FDA-approved treatment available in ready-to-use form. It belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is noted for its rapid action and potential for lower gastrointestinal side effects compared to other NSAIDs.
The NDS for ELYXYB was filed in December 2023, and the approval process in Canada is expected to take approximately 12 months, subject to review cycles and additional information requests by Health Canada.
Market research indicates that there is a significant demand for effective and safe migraine treatments, particularly for patients who do not respond to triptan therapy or have contraindications to its use. Clinical studies have shown that ELYXYB can provide pain relief in as little as 15 minutes, with about 50% of patients experiencing significant pain relief within 45 minutes when compared to a placebo.
The migraine therapeutics market in Canada is projected to reach around $400 million by 2025, with over 2.7 million Canadians affected by severe migraines. ELYXYB's potential market entry could address a considerable portion of this patient population.
Scilex's portfolio also includes ZTlido® for neuropathic pain associated with postherpetic neuralgia and Gloperba® for gout flare prophylaxis, with the latter expected to launch in the first half of 2024. The company has additional product candidates in various stages of clinical development.
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