Scilex Holding Company Announces that the U.S. FDA Has Acknowledged the Submission of Our Supplemental New Drug Application for ELYXYB® in Acute Pain Indication

Rhea-AI Summary

Scilex Holding Company (Nasdaq: SCLX) has announced that the U.S. FDA has acknowledged the submission of their Supplemental New Drug Application (SNDA) for ELYXYB® in the indication of acute pain. Scilex is a revenue-generating company focused on developing and commercializing non-opioid pain management products for both acute and chronic pain. The company is also exploring opportunities in neurodegenerative and cardiometabolic diseases through a proposed joint venture with IPMC Company.

Positive

• FDA acknowledgment of SNDA for ELYXYB® in acute pain indication.
• Focus on non-opioid pain management products.

Negative

• None.

Insights

Pharmaceutical Industry Analyst

The FDA's acknowledgment of Scilex's SNDA for ELYXYB® marks a important regulatory milestone in the company's strategy to expand its non-opioid pain management portfolio. ELYXYB®, currently approved for acute migraine, could potentially address a broader market with the acute pain indication. The acute pain management market represents a significant opportunity, particularly given the ongoing efforts to reduce opioid dependence in pain management.

The SNDA acknowledgment initiates the formal review process, which typically spans several months. This regulatory pathway is generally less complex than the original NDA process since the drug's safety profile is already established. For a smaller company like Scilex, with a market cap of $57.7 million, expanding ELYXYB's approved indications could be particularly meaningful for revenue diversification.

However, it's important to note that this is just the beginning of the review process. The FDA's acknowledgment of submission does not guarantee approval and investors should monitor upcoming regulatory milestones. The company's focus on non-opioid pain management aligns with current healthcare priorities, though market success would still depend on factors like pricing strategy and market penetration upon potential approval.

PALO ALTO, Calif., Jan. 22, 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, in neurodegenerative and cardiometabolic disease, today announced that the U.S. FDA has acknowledged the submission of our Supplemental New Drug Application (SNDA) for ELYXYB^® in acute pain indication.

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 Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability.

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”) 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 Elyxyb’s potential as an acute pain therapy, whether the FDA approves the sNDA for ELYXYB, ELYXYB’s potential to further expand Scilex’s non-opioid portfolio and its potential to address high unmet needs in treating acute pain, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, 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: the risk that the sNDA for ELYXYB may not be approved by the U.S. FDA, Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, 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; risks related to COVID-19 (and other similar disruptions); 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, 2023 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

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 significance of the FDA acknowledgment of Scilex's SNDA for ELYXYB®?

The FDA acknowledgment of Scilex's SNDA for ELYXYB® is a important step in the regulatory process, potentially leading to approval for use in acute pain management.

What does Scilex's SNDA submission for ELYXYB® entail?

Scilex's SNDA submission for ELYXYB® involves seeking FDA approval for the drug's use in managing acute pain, expanding its current indications.

How does Scilex's focus on non-opioid pain management impact its market potential?

Scilex's focus on non-opioid pain management positions the company strategically in a market that seeks alternatives to opioid treatments, potentially increasing its market share and revenue.

What are the potential benefits of ELYXYB® for acute pain?

ELYXYB® offers a non-opioid option for acute pain management, which could reduce dependency on opioid medications and provide effective pain relief.

What future plans does Scilex have beyond pain management?

Scilex plans to expand into neurodegenerative and cardiometabolic diseases through a proposed joint venture with IPMC Company.