Scilex Holding Company Announces Approval of a New Drug Submission (NDS) from the Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB®’s Acute Treatment of Migraine With or Without Aura in Canada

Rhea-AI Summary

Scilex Holding Company (NASDAQ: SCLX) has received approval from Health Canada for ELYXYB®, their ready-to-use oral solution for acute migraine treatment. ELYXYB® is the only FDA-approved oral solution in its category and demonstrates pain relief in as fast as 15 minutes, with significant relief compared to placebo within 45 minutes in approximately 50% of patients.

The Canadian market represents a significant opportunity, with over 2.7 million Canadians affected by migraines and the migraine therapeutics market projected to reach $400 million by 2025. The drug, which is manufactured in Canada, offers a first-line treatment option with potentially lower gastrointestinal side effects compared to other NSAIDs.

Positive

• Received Health Canada approval for ELYXYB®, expanding market reach
• Targets large Canadian migraine market worth $400M by 2025
• Fast-acting treatment showing pain relief in as little as 15 minutes
• Product manufactured in Canada, reducing supply chain complexity

Negative

• Faces competition in crowded NSAID market
• 50% efficacy rate at 45 minutes indicates treatment may not work for all patients

Insights

Pharmaceutical Regulatory Expert

The Health Canada approval for ELYXYB® represents a significant regulatory milestone for Scilex in the migraine treatment space. This approval is particularly notable as it grants access to Canada's migraine therapeutics market, which is projected to reach $400 million by 2025 with over 2.7 million affected patients.

ELYXYB® holds several distinguishing clinical advantages in this space. As the only FDA-approved ready-to-use oral solution for acute migraine treatment, it offers a unique administration format. The drug demonstrated rapid efficacy in clinical trials, with pain relief beginning in as little as 15 minutes and significant relief compared to placebo within 45 minutes for approximately 50% of patients.

From a positioning perspective, ELYXYB® addresses two substantial unmet needs in the Canadian migraine market: patients with insufficient response to triptan therapy and those with contraindications to triptans. Its NSAID classification combined with potentially reduced gastrointestinal side effects provides a differentiated clinical profile for physicians seeking alternatives to standard treatments.

The fact that ELYXYB® is already manufactured in Canada creates potential operational advantages for Scilex, potentially streamlining supply chain logistics and reducing importation complexities. This regulatory approval effectively removes the final significant barrier to commercialization in a key pharmaceutical market, representing clear progression in Scilex's international expansion strategy.

Financial Analyst

This regulatory approval unlocks meaningful revenue potential for Scilex by providing access to Canada's sizable migraine market. With a current market capitalization of just $41.8 million, even modest penetration into a $400 million therapeutic area could significantly impact Scilex's financial performance.

The strategic value extends beyond immediate sales potential. Canada ranks among the top 10 global pharmaceutical markets and serves as the second-largest export destination for U.S. pharmaceuticals. This approval creates a foundation for potential further international expansion, as regulatory success in major markets often facilitates approvals in additional territories.

ELYXYB®'s differentiated product profile addresses specific patient segments currently underserved by existing treatments. This targeted approach could enable efficient marketing spend and potentially higher pricing power compared to more generalized pain management solutions.

For context, this represents Scilex's continued execution on its stated strategy as "an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products." The Canadian approval adds a new revenue stream to their portfolio alongside existing products ZTlido®, ELYXYB® (U.S.), and Gloperba®.

While commercialization timelines and specific revenue projections weren't disclosed, this approval removes a critical regulatory hurdle and enables Scilex to proceed with Canadian market entry for a product already manufactured in the country – suggesting potential for relatively rapid commercialization.

• 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
  

PALO ALTO, Calif., April 15, 2025 (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 and, following the formation of its proposed joint venture with IPMC Company, neurodegenerative and cardiometabolic disease, today announced that it has received approval of a New Drug Submission (NDS) from the Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB^®’s 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 welcome the approval of ELYXYB^® (celecoxib oral solution) to the acute treatment options for nearly five million Canadians living with migraine. This unique option has proven efficacy and safety that can help patients achieve rapid pain freedom,” said Dr. Christine Lay, Professor of Neurology and Founding Director of the Headache program at the University of Toronto.

“Canada is consistently among the top 10 global pharmaceutical markets. It is the second largest export destination for U.S. pharmaceuticals. It is also a strategic market for expansion globally, providing opportunities for increased international recognition and regulatory harmonization. We are very excited to expand the use of ELYXYB^® to Canada, which is especially meaningful given the drug is manufactured in Canada, and to start helping Canadian patients who suffer from acute migraine,” said Dmitri Lissin, MD, SVP and Chief Medical Officer of Scilex.

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com

For more information on ZTlido^®, including Full Prescribing Information, refer to www.ztlido.com

For more information on ELYXYB^®, including Full Prescribing Information, refer to www.elyxyb.com

For more information on Gloperba^®, including Full Prescribing Information, refer to www.gloperba.com

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About Scilex Holding Company

Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido^® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB^®, a potential 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; and (iii) Gloperba^®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia.

Scilex Holding Company is headquartered in Palo Alto, California.

About Semnur Pharmaceuticals, Inc.

Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly-owned subsidiary of Scilex, is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica.

Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the estimates for the migraine therapeutic market and the patient population for migraine in Canada, ELYXYB’s potential to further expand Scilex’s non-opioid portfolio and its potential to address high unmet needs in treating acute migraine, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, and cardiometabolic disease.

Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to gain market acceptance of ELYXYB^® in Canada; Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, or cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.

Contacts:
Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

Email: investorrelations@scilexholding.com

Website: www.scilexholding.com

Reference

1)  Source: Celecoxib Oral Solution Approved for Acute Migraine March 2020.
     https://www.neurologylive.com/view/celecoxib-oral-solution-gets-goahead-for-acute-migraine

2)  Source: Mordor Intelligence - MIGRAINE THERAPEUTICS MARKET (2020-2025)

3)  Source: Acute Migraine Headache: Treatment Strategies.
     https://www.aafp.org/pubs/afp/issues/2018/0215/p243.html

4)  Data on file. Scilex Holding Company

5)  Lipton RB, et al. J Pain Res 2021; 14:549-560.

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.

ZTlido^® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

Gloperba^® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

ELYXYB^® is a registered trademark owned by Scilex Holding Company.

All other trademarks are the property of their respective owners.

© 2025 Scilex Holding Company All Rights Reserved.

FAQ

What is the market size for SCLX's ELYXYB in Canada?

The Canadian migraine therapeutics market is estimated to reach approximately $400 million by 2025, with over 2.7 million Canadians affected by migraines.

How quickly does SCLX's ELYXYB work for migraine relief?

ELYXYB demonstrates pain relief in as little as 15 minutes, with significant pain relief compared to placebo within 45 minutes in approximately 50% of patients.

What advantages does SCLX's ELYXYB have over other migraine treatments?

ELYXYB is the only FDA-approved ready-to-use oral solution for acute migraine treatment and has potentially lower gastrointestinal side effects compared to other NSAIDs.

What regulatory approval did SCLX receive for ELYXYB in Canada?

Scilex received approval of a New Drug Submission (NDS) from Health Canada's Pharmaceutical Drugs Directorate for ELYXYB's acute treatment of migraine.