Scilex Holding Company Announces Acceptance of Abstract for Poster and Oral Presentation at the Annual Meeting of the American Academy of Pain Medicine (AAPM)

PALO ALTO, Calif., Feb. 27, 2024 (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, today announced acceptance of an abstract for poster and oral presentation at the 2024 Annual Meeting of the American Academy of Pain Medicine (AAPM) which will take place on March 7-10, 2024 in Scottsdale, Arizona.

• Titled: Decreased Opioid Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch: A Retrospective Claims Analysis (First author: Srinivas Nalamachu, M.D.). Oral Presentation Schedule: Saturday, March 9, 2024; 10:15-10:20AM (MST)
  
  
  • In this retrospective analysis of OPTUM claims data, we evaluated over 6,000 patients with neuropathic pain who were treated with either ZTlido^® or a generic lidocaine 5% patch and were also receiving an opioid. 
    
  • The study demonstrated a greater proportion of patients treated with ZTlido^® (lidocaine topical system 1.8%) were able to either decrease or discontinue opioids (51.9% versus 45.5%, p=0.021) compared to patients treated with a generic lidocaine 5% patch. In addition, patients treated with ZTlido^® had a more significant reduction in opioid dose relative to a generic lidocaine 5% patch. 
  • Regardless of the type of neuropathic pain, ZTlido^® was associated with a greater opioid-sparing effect than a generic lidocaine 5% patch. 
  • While a generic lidocaine 5% patch has been well established to reduce analgesic use; this study is the first to evaluate the opioid-sparing effect of two bioequivalent formulations of lidocaine patches (ZTlido^® and a generic lidocaine 5% patch).
  • The novel design of ZTlido^® has demonstrated significantly better adhesion performance than a generic lidocaine 5% patch. Greater adhesion provides improved medication delivery and pain relief for patients. As a result, improved adhesion for ZTlido^® is likely contributing to more optimal pain management and enable reduction/discontinuation of opioid dose.
    

• Title: Retrospective Claims Analysis of Decreased Healthcare Visits and Costs with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch (First Author: Srinivas Nalamachu, MD.) Oral Presentation Schedule: Saturday, March 9, 2024; 10:20-10:25 AM (MST)
  
  
  • In a retrospective analysis of over 889,000 patients, we used Symphony Health claims data to evaluate the impact of ZTlido^® (lidocaine topical system 1.8%) versus lidocaine 5% patch on healthcare resource utilization, including emergency room visits, office/clinic visits, outpatient visits, and pain procedures.
    
  • Across the studied care settings, treatment with ZTlido^® was associated with either a reduction or insignificant increase in healthcare resource utilization, while lidocaine 5% patch was associated with consistently and significantly large increases in healthcare resource utilization.
  • These results are consistent with and confirm early reported data from another retrospective claims analysis (Painweek 2023)
  • This is the first study evaluating the impact on healthcare resource utilization of two bioequivalent formulations of lidocaine patch (ZTlido^® and lidocaine 5% patch).
  • The novel design of ZTlido^® has demonstrated significantly better adhesion performance than lidocaine 5% patch. Greater adhesion provides improved medication delivery and pain relief for patients. As a result, improved adhesion for ZTlido^® is likely contributing to more optimal pain management and may result in reduced healthcare resource utilization.
    

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.

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. 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 are 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, expected to launch in 2024.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA^TM” 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; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial 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 and a Phase 2 clinical trial is expected to commence in 2024.

Scilex Holding Company 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 results from the ZTlido^® study and statements regarding the potential for ZTlido^® to have greater opioid sparing effects compared to generic lidocaine patches, Scilex’s plans to launch Gloperba in 2024 and plans to initiate Phase 2 trial in 2024 for SP-104.  

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 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, 2022 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, 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 the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

All other trademarks are the property of their respective owners.

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