Scilex Announces New ELYXYB® Patent for Acute Pain Treatment

Scilex Holding Company has announced that the U.S. Patent and Trademark Office has approved various claims from their patent application number 17/562,229. This approval will result in a new patent being issued to Scilex by late 2024, thereby strengthening the company's intellectual property for its acute migraine treatment product, ELYXYB®. ELYXYB® is a liquid formulation of celecoxib, designed using micro-encapsulation technology. It stands out as the only FDA-approved, ready-to-use oral solution for the acute treatment of migraines in adults, with or without aura. This formulation provides a non-opioid therapeutic alternative to traditional painkillers like acetaminophen, which is a leading cause of acute liver failure in the U.S.

The market for oral migraine drugs in the U.S. was estimated to be $1.8 billion in 2022. ELYXYB® offers a rapid onset of action and is positioned as a first-line treatment for migraine, supported by evidence suggesting non-steroidal anti-inflammatory drugs (NSAIDs) are effective for this purpose. It is noted for potentially having the lowest gastrointestinal side effects among NSAIDs. DelveInsight estimates there were about 100 million cases of acute pain in the U.S. in 2021, with the total market for acute pain being around $3 billion.

Clinical feedback indicates a significant demand for quick and safe alternatives to current migraine treatments, particularly for patients who do not respond adequately to triptan therapy or have contraindications for its use. ELYXYB® has demonstrated its efficacy in clinical trials, offering pain relief in as little as 15 minutes and significant pain relief compared to placebo within 45 minutes for approximately 50% of patients.

Jaisim Shah, CEO and President of Scilex, has expressed enthusiasm about the potential of ELYXYB® since its U.S. launch in April 2023. He emphasized that the new patents would enhance Scilex's ability to provide effective pain management tools and support future applications for acute pain treatments.

Scilex Holding Company focuses on developing and commercializing non-opioid pain management products for both acute and chronic pain. Their commercial products include ZTlido® (a lidocaine topical system for postherpetic neuralgia), ELYXYB®, and Gloperba® (a liquid oral colchicine for gout flare prophylaxis). Scilex is also developing three product candidates: SP-102 (SEMDEXA™, a corticosteroid gel for sciatica), SP-103 (a triple-strength lidocaine topical system for chronic neck pain), and SP-104 (a low-dose naltrexone hydrochloride for fibromyalgia treatment). The company is headquartered in Palo Alto, California.

Additionally, Semnur Pharmaceuticals, a subsidiary of Scilex, is working on non-opioid pain therapies, with SP-102 being its flagship program. This novel gel formulation, administered epidurally, is intended for patients with moderate to severe chronic radicular pain or sciatica. Semnur is also based in Palo Alto, California.

Denali Capital Acquisition Corp. is a blank check company focused on mergers and acquisitions. It aims to effect a business combination with one or more entities, offering a platform for companies like Semnur to expand their market reach.