Scilex Holding Company Announces Pain Medicine News Published Retrospective Claims Data on ZTlido® vs. Lidocaine 5% Patch

Rhea-AI Summary

Scilex Holding Company (SCLX) announced the publication of retrospective claims data in Pain Medicine News comparing ZTlido® to lidocaine 5% patch. The study analyzed claims data from the Optum Claims database between May 2018 and September 2023 for patients with neuropathic pain.

Key findings showed that ZTlido® users demonstrated better outcomes in opioid reduction compared to the 5% lidocaine patch:

• 51.9% of ZTlido® patients decreased or discontinued opioid use vs 45.5% for the 5% patch
• 21.3% of ZTlido® patients achieved ≥20% opioid reduction vs 13.4% for the 5% patch (P=0.0008)
• ZTlido® patients showed minimal change in baseline opioid use (+3.1%, P=0.146) while 5% patch users had significant increase (+42.9%, P<0.001)

Positive

• ZTlido® demonstrated superior efficacy in reducing opioid dependence compared to generic alternatives
• 51.9% of ZTlido® patients reduced or discontinued opioid use vs 45.5% for generic patch
• ZTlido® showed statistically significant better results in achieving ≥20% opioid reduction (21.3% vs 13.4%, P=0.0008)

Negative

• ZTlido® patients still showed a slight increase in baseline opioid use (+3.1%)

Insights

Medical Research Analyst

The published claims data comparing ZTlido® to generic lidocaine patches reveals significant clinical advantages in opioid reduction outcomes. The 51.9% decrease or discontinuation rate for ZTlido® versus 45.5% for generic patches demonstrates superior efficacy in reducing opioid dependence. Most notably, the stark contrast in baseline opioid use changes (+3.1% for ZTlido® vs +42.9% for generic) suggests ZTlido's superior pain management capabilities.

The study's 5-year timeframe (2018-2023) and use of the comprehensive Optum Claims database provides robust real-world evidence. The 20%+ reduction in opioid use achieved by 21.3% of ZTlido® patients compared to 13.4% of generic patch users (P=0.0008) represents a statistically significant clinical advantage that could reshape treatment protocols for neuropathic pain conditions.

Financial Analyst

This data publication strengthens ZTlido's market positioning against generic competitors. With a market cap of $72.86M, SCLX's flagship product now has compelling evidence to support premium pricing and potential market share expansion. The demonstrated superiority in reducing opioid use could drive increased insurance coverage and physician preference, particularly given the ongoing opioid crisis.

The timing of this publication in Pain Medicine News, a leading trade publication, maximizes visibility among key prescribers. The robust data showing ZTlido's advantages over generic alternatives could accelerate revenue growth through both volume increases and maintained pricing power. For investors, this represents a potential catalyst for revenue expansion in the neuropathic pain market.

• More patients treated with ZTlido^® saw either a decrease or discontinuation of opioid use compared with those treated with the 5% patch (51.9% vs. 45.5%).
• Of all study patients reporting a decrease in opioid use, significantly more in the ZTlido^® group experienced a 20% or greater reduction in opioid use, compared with those treated with 5% lidocaine patch (21.3% vs. 13.4%; P=0.0008).
• Patients on ZTlido^® had a non-significant change in their baseline opioid use (+3.1%; P=0.146), while those using the 5% patch experienced a significant increase in opioid use from baseline (+42.9%; P<0.001).
  

PALO ALTO, Calif., Jan. 13, 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 Pain Medicine News published retrospective claims data on ZTlido^® vs. lidocaine 5% patch.

Pain Medicine News, the premier trade publication in the pain management space, published decreased opioid utilization demonstrated with ZTlido^® (lidocaine topical system 1.8%) in the magazine’s December edition. The article concluded that retrospective claims data showed that Scilex Pharmaceuticals’ flagship product, the branded ZTlido^® lidocaine patch, was associated with less use of opioid analgesics in patients with neuropathic pain compared with the 5% lidocaine patch (generic). The researchers looked at claims with a diagnosis of neuropathic pain (postherpetic neuralgia, diabetic peripheral neuropathy or low back pain) in the Optum Claims database from May 1, 2018, to Sept. 30, 2023.

Among the key conclusions were that:

• More patients treated with ZTlido^® saw either a decrease or discontinuation of opioid use compared with those treated with the 5% patch (51.9% vs. 45.5%).
• Of all study patients reporting a decrease in opioid use, significantly more in the ZTlido^® group experienced a 20% or greater reduction in opioid use, compared with those treated with 5% lidocaine patch (21.3% vs. 13.4%; P=0.0008).
• Patients on ZTlido^® had a non-significant change in their baseline opioid use (+3.1%; P=0.146), while those using the 5% patch experienced a significant increase in opioid use from baseline (+42.9%; P<0.001).
  

This study further affirms the difference between ZTlido^®, as a second-generation lidocaine topical system, versus older, conventional lidocaine patches, and highlights the downstream impact conferred by advanced technology and improved adhesion. The full article may be accessed in the print edition of Pain Medicine News or online in the digital edition at this link: December issue of Pain Medicine News

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) (“SEMDEXATM” 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, for which Phase 1 trials were completed in the second quarter of 2022.

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 Pain Medicine News published retrospective claims data on ZTlido^® vs. lidocaine 5% patch.

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: risks associated with the Board’s right to change the Record Date and/or revoke the Dividend; 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 Scilex Holding Company to use the registered trademark.

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

All other trademarks are the property of their respective owners.

© 2024 Scilex Holding Company All Rights Reserved.

FAQ

What are the key findings of the ZTlido® vs lidocaine 5% patch study published in Pain Medicine News for SCLX?

The study showed ZTlido® patients had better outcomes with 51.9% reducing/discontinuing opioid use vs 45.5% for the 5% patch, and 21.3% achieving ≥20% opioid reduction vs 13.4% for the generic patch.

How did ZTlido® affect opioid usage compared to the generic 5% lidocaine patch in the 2023 study?

ZTlido® patients showed minimal increase in baseline opioid use (+3.1%) compared to generic patch users who had significant increase (+42.9%).

What was the timeframe and database used for the SCLX ZTlido® study?

The study analyzed claims from the Optum Claims database from May 1, 2018, to September 30, 2023.

What types of pain conditions were included in the 2023 ZTlido® study by SCLX?

The study included patients with neuropathic pain conditions: postherpetic neuralgia, diabetic peripheral neuropathy, and low back pain.