ZTlido (lidocaine patch 1.8%) / Sorrento - LARVOL DELTA

Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results for the Quarter Ended September 30, 2024 (GlobeNewswire) - "The Company estimates that: ZTlido net sales for the quarter ended September 30, 2024 were in the range of $11.0 million to $13.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 9% to 29%. Total product net sales for the quarter ended September 30, 2024 were in the range of $12.0 million to $14.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 19% to 39%."

Sales • Pain

Retrospective Claims Analysis of Decreased Healthcare Visits and Costs with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch (PAINWeek 2024) - "55,106 patients had LP and 955 had LTS index therapy. From pre- to post-index time periods, average number of office visits, ER visits, and pain procedures (PP) decreased for LTS vs increased for LP (Office: -4% LTS vs 11% LP, p=­­ < 0.01; ER: -12% LTS vs 12% LP; PP: -9% LTS vs 20% LP, p=­ < 0.01). As well, healthcare costs decreased for LTS vs increased for LP for outpatient (-9% LTS vs 8% LP) and ER visits (-5% LTS, 9% LP, p=­ 0.02).Conclusions/Implications for future research and/or clinical care: In these data of neuropathic pain patients, HCRU and associated costs decreased for LTS patients, and increased for LP patients, after starting either therapy."

Retrospective data • Back Pain • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Decreased Opioid Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch: A Retrospective Claims Analysis (PAINWeek 2024) - "Background: CDC Clinical Practice Guidelines for Prescribing Opioids for Pain recommends maximizing non-opioid pharmacologic therapies and reducing the use of opioids for the treatment of chronic pain1. The final analysis included 6,014 patients taking opioids and either LTS or LP index treatment. 51.9% of LTS patients experienced either a decrease or discontinuation of opioid use in the post-prescription period compared to 45.5% of LP patients (Chi-square test, p=0.021). LTS patients had a non-significant change in pre- versus post-prescription median Morphine Milligram Equivalents (MME) (3.1% increase, Wilcoxon signed rank test, p=0.146); while LP patients experienced a significant increase in pre-versus post-prescription median MME (42.9% increase, Wilcoxon signed rank test, p< 0.001)."

Retrospective data • Back Pain • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Decreased Cost Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch: A Retrospective Claims Analysis. (PAINWeek 2024) - "In total, patients treated with LTS demonstrated a reduction in cost while patients treated with LP were associated with an increase in cost in the post-index setting. The median cost of office visits per LTS patient was $2518 pre-index and $2439 post-index (-3%, p=0.003), the median cost of ER/urgent care visits per LTS patient was $1574 pre-index and $1017 post-index (-35%, p=0.663), the median cost of outpatient visits per LTS patient was $2977 pre-index and $2984 post-index (+0.2%, p=0.906 ) and the median cost of pain procedures per LTS patient was $1150 pre-index and $1155 post-index (+0.4%, p=0.107).In contrast, the median cost of office visits per LP patient was $1862 pre-index and $1898 post-index (+2%, p=0.04), the median cost of ER/urgent care visits per LP patient was $2558 pre-index and $2501 post-index (-2%, p=0.624), the median cost of outpatient visits per LP patient was $3636 pre-index and $3926 post-index (+8%, p< 0.001), and the median cost of pain..."

Retrospective data • Back Pain • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain

Decreased Opioid Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch: A Retrospective Claims Analysis (PAINWeek 2024) - "Sponsored By Scilex This session is not certified for credit. The final analysis included 6,014 patients taking opioids and either LTS or LP index treatment. 51.9% of LTS patients experienced either a decrease or discontinuation of opioid use in the post-prescription period compared to 45.5% of LP patients (Chi-square test, p=0.021). LTS patients had a non-significant change in pre- versus post-prescription median Morphine Milligram Equivalents (MME) (3.1% increase, Wilcoxon signed rank test, p=0.146); while LP patients experienced a significant increase in pre-versus post-prescription median MME (42.9% increase, Wilcoxon signed rank test, p< 0.001)."

Retrospective data • Back Pain • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Decreased Cost Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch: A Retrospective Claims Analysis (PAINWeek 2024) - "In total, patients treated with LTS demonstrated a reduction in cost while patients treated with LP were associated with an increase in cost in the post-index setting. The median cost of office visits per LTS patient was $2518 pre-index and $2439 post-index (-3%, p=0.003), the median cost of ER/urgent care visits per LTS patient was $1574 pre-index and $1017 post-index (-35%, p=0.663), the median cost of outpatient visits per LTS patient was $2977 pre-index and $2984 post-index (+0.2%, p=0.906 ) and the median cost of pain procedures per LTS patient was $1150 pre-index and $1155 post-index (+0.4%, p=0.107).In contrast, the median cost of office visits per LP patient was $1862 pre-index and $1898 post-index (+2%, p=0.04), the median cost of ER/urgent care visits per LP patient was $2558 pre-index and $2501 post-index (-2%, p=0.624), the median cost of outpatient visits per LP patient was $3636 pre-index and $3926 post-index (+8%, p< 0.001), and the median cost of pain..."

Retrospective data • Back Pain • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain

Scilex Holding Company to Present Oral, Poster Presentations and Symposia on ZTlido (lidocaine topical system) at the 2024 Annual PAINWeek Conference in Las Vegas, NV on September 3-5, 2024 (GlobeNewswire) - "Scilex Holding Company...today announced oral, poster presentations, and symposia on ZTlido (lidocaine topical system) at the 2024 Annual PAINWeek conference in Las Vegas, NV on September 3-5, 2024."

Clinical • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Enters into Master Distributor Agreement Among CH Trading Group and Devart Middle East for the Distribution of ZTlido in Morocco, Tunisia, Libya, Jordan, Iraq, and South Africa (GlobeNewswire) - "Scilex Holding Company...today announced a Master Distributor Agreement with Devart Middle East Food Supplements ('Devart Middle East'), as Master Distributor, and CH Trading Group LLC ('CH Trading Group'), as Territories Distributor, to expand the distribution of ZTlido into the countries of Morocco, Tunisia, Libya, Jordan, Iraq, and South Africa ('Designated Territories')....Under the Master Distributor Agreement, Devart Middle East assumes the responsibility, among other things, of promoting, marketing, selling and distributing ZTlido, and potentially other Scilex products, through a network of business associates, into the above Designated Territories."

Licensing / partnership • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results for the Month Ended July 31, 2024 (GlobeNewswire) - "Scilex Holding Company...today provided certain preliminary unaudited financial results for the month ended July 31, 2024. Scilex generates continuous sales growth in ZTlido going into third quarter of 2024 with preliminary net sales for ZTlido in the range of $4.0 million to $5.0 million....Total product net sales for the month ended July 31, 2024 were in the range of $4.3 million to $5.3 million, compared to $2.8 million for the same period last year, representing growth in the range of approximately 54% to 89%."

Sales • CNS Disorders • Pain

Scilex Holding Company Announces Collaboration to Leverage ACEA Therapeutics’ R&D Expertise and Local Market Connections to Support the Expansion of ZTlido Program in ex-US and Potentially Provide Additional Access to Patients in Certain Key Markets in Far East Region (Yahoo Finance) - "Scilex Holding Company...today announced that that it has entered into a Memorandum of Understanding (MOU) for collaboration agreement with ACEA, a China-based company focused on the development of innovative treatments for high unmet needs. Under the terms of the MOU, ACEA may receive exclusive rights to develop and commercialize of ZTlido in mainland China, Taiwan, Hong Kong, Macau, including the current formulation and a right of first negotiation for a future next generation formulation of a 3X version of ZTlido, SP-103. The MOU provides Scilex with the opportunity to expand collaboration with ACEA across other products in Scilex’s non-opioid pain management portfolio in the Greater China region."

Licensing / partnership • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results For Gross and Net Sales for ZTlido for the First Quarter 2024; Implements Planned 2024 Commercial Ramp for Additional Opioid Sparing Product and Reduction of R&D and Other Administrative Expenses (GlobeNewswire) - "Scilex Holding Company...today provided certain preliminary unaudited financial results for gross and net sales for ZTlido for the quarter ended March 31, 2024, and proposed plans to reduce research and development and other administrative expenses in 2024....ZTlido gross sales for the first quarter of 2024 were in the range of $34.0 million to $38.0 million, compared to $27.5 million for the first quarter of 2023, representing growth in the range of approximately 24% to 38%. ZTlido net sales for the first quarter of 2024 were in the range of $12.0 million to $13.0 million, compared to $10.6 million for the first quarter of 2023, representing growth in the range of approximately 13% to 23%."

Sales • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Announces Launching of Co-Pay Programs for Both ZTlido and ELYXYB for Commercially Insured Patients and the addition of ELYXYB to a Multi-State Medicaid Pharmaceutical Purchasing Group to Its Purchasing Pool (Yahoo Finance) - "Scilex Holding Company...today announced launching of co-pay programs for both ZTlido and ELYXYB with the out-of-pocket costs for its product portfolio for commercially insured patients capped at $25 monthly, with certain eligible patients paying as low as $0. This applies to the Company's postherpetic neuralgia pain product, ZTlido, and migraine product, ELYXYB....Additionally, on April 1, 2024, a multi-state Medicaid pharmaceutical purchasing group added ELYXYB to its purchasing pool to make it eligible for thirteen States’ Medicaid programs."

Medicaid • Reimbursement • CNS Disorders • Migraine • Neuralgia • Pain • Peripheral Neuropathic Pain

Decreased health care resource utilization with lidocaine topical system 1.8% compared with lidocaine 5% patch: A retrospective claims analysis (AMCP 2024) - No abstract available

HEOR • Retrospective data

Scilex Holding Company Announces New Out-of-Pocket Costs for Commercially Insured Patients (GlobeNewswire) - "Scilex Holding Company...today announced that the out-of-pocket costs for its product portfolio for commercially insured patients is expected to be capped at $25 monthly, with certain eligible patients paying as low as $0. This applies to the Company's postherpetic neuralgia pain product, ZTlido, migraine product, ELYXYB....Scilex has made significant investments to improve patient affordability and access to its products and continues to build on the Company's commitment to provide non-opioid pain management products to patients."

Reimbursement • CNS Disorders • Migraine • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Announces Issuance of Halal Certification for its ZTlido product by Circle H International, Inc. (GlobeNewswire) - "Scilex Holding Company...today announced that it received Halal Certification of its commercial product ZTlido, indicating that ZTlido has undergone rigorous assessment to determine that it is permissible or acceptable in accordance with Islamic standards. The Halal certification was issued under the authority of Circle H International, Inc. (“Circle H”) and offers the Company the opportunity to provide ZTlido to Islamic markets globally. This announcement supports the global expansion strategy for Scilex, which Scilex anticipates will include a presence in the Middle East and North Africa (MENA) region with an initial priority focus on the UAE and Saudi Arabia."

Commercial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Announces that ZTlido Achieves a Major Milestone - Over One Million Patients Treated Since its Launch - and Two Additional Milestones Met (GlobeNewswire) - "Scilex Holding Company...today announced ZTlido has reached three major milestones since it launched in October 2018. The following three milestones are a testament to the perceived confidence that patients and health care providers have in ZTlido: Over one million patients are estimated to have been treated with ZTlido since its launch according to Symphony Health prescription data. ZTlido is now the number one prescribed non-opioid branded pain medication by pain specialists in the United States, based on Symphony Health prescription data gathered from January 2023 to November 2023. Patients report 89% satisfaction with ZTlido, in a 2023 patient survey conducted by Scilex (n=100, rating as 'completely' or 'mostly' satisfied with ZTlido treatment)."

Commercial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The Fiscal Year Ended December 31, 2023, Based On Currently Available Information (BioSpace) - "ZTlido gross sales for the fiscal year ended December 31, 2023 were in the range of $145.0 million to $150.0 million, compared to $96.0 million for the fiscal year ended December 31, 2022, representing growth in the range of approximately 51% to 56%. ZTlido net sales for the fiscal year ended December 31, 2023 were in the range of $46.0 million to $52.0 million, compared to $38.0 million for the fiscal year ended December 31, 2022, representing growth in the range of approximately 21% to 37%."

Sales • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Announces that According to Prescription Data from Symphony Health, ZTlido is the Most Prescribed Non-Opioid Branded Pain Treatment By Pain Specialists (BioSpace) - "Scilex Holding Company...announced that according to prescription data from Symphony Health, ZTlido^® is the most prescribed non-opioid, branded pain treatment prescribed by pain specialists. Total ZTlido^® NRx (New Drug Prescription) market share grew to 14.2% in October 2023, compared to 11.8% in October 2022 according to prescription data from Symphony Health."

Commercial • CNS Disorders • Pain

Scilex Holding Company announces the addition of ZTlido (lidocaine topical system) as a preferred agent to the Medicaid Preferred Drug List (PDL) of the State of Tennessee (GlobeNewswire) - "Scilex Holding Company...today announced that the State of Tennessee added ZTlido^® as a preferred agent to the Medicaid Preferred Drug List effective as of October 1, 2023. This change has the potential to improve access to ZTlido^® for all eligible patients which includes approximately 1,500,000 adult lives between the ages of 19 to 64."

Reimbursement • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company announces successful FDA audit of enhanced ZTlido manufacturing facility in Japan (BioSpace) - "Scilex Holding Company...today announced the successful completion of a Good Manufacturing Practices (GMP) inspection by the U.S. Food and Drug Administration (FDA) of the enhanced manufacturing facility of Oishi Koseido Co., Ltd. (Oishi) for ZTlido located in Tosu, Saga, Japan. This successful audit allows Scilex to continue commercializing ZTlido product manufactured at 250kg scale at Oishi’s facility. This facility is also the manufacturing site for SP-103 (lidocaine topical system, atriple strength formulation of ZTlido) that recently completed trials in acute back pain and neck pain."

Commercial • Back Pain • CNS Disorders • Lumbar Back Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Generates Monthly Revenue In November 2023 And Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The One Month Ended November 2023, And Year-To-Date Through November 30, 2023, Based On Currently Available Information [Google translation] (stock.yahoo) - "ZTlido gross sales for November 2023 were in the range of $14.0 million to $15.0 million with year-to-date gross sales through November 2023 in the range of $125.0 million to $135.0 million, compared to $84.6 million for year-to-date through November 2022, representing growth in the range of approximately 48% to 60%...ZTlido net sales for November 2023 were in the range of $3.9 million to $4.5 million with year-to-date net sales through November 2023 in the range of $40.0 million to $43.0 million, compared to $33.9 million for year-to-date through November 2022, representing growth in the range of approximately 18% to 27%."

Sales • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Announces Issuance of a Second New Patent in the U.S. for Its Lead Commercial Product ZTlido (lidocaine topical system) for a Method of Relieving Pain Through the Application of a Non-Aqueous Lidocaine-Containing Patch (GlobeNewswire) - "Scilex Holding Company...today announced that the U.S. Patent and Trademark Office has issued a second new patent, No. 11,786,455 (the 'Patent'), further strengthening the Company’s intellectual property position and coverage for its lead commercial product, ZTlido® (lidocaine topical system) 1.8%, which will expire in 2031. The Patent...covers a non-aqueous lidocaine patch with certain specifications, as well as a method of relieving pain through the application of a non-aqueous lidocaine-containing patch. These two new issued patents No. 11,786,455 and No. 11,793,766 will be listed in the U.S. Food and Drug Administration’s Orange Book in connection with ZTlido." "

Patent • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Topical Delivery Systems Effectively Transport Analgesics to Areas of Localized Pain via Direct Diffusion. (PubMed, Pharmaceutics) - "An investigational TDS containing 108 mg lidocaine (SP-103, 5.4% lidocaine), a commercially available TDS containing 36 mg lidocaine (ZTlido, 1.8% lidocaine), and a topical pain relief gel (Pennsaid, 2% diclofenac) were tested...The data showed a clear contribution of diffusive transport to lidocaine concentration, with SP-103 5.4% resulting in a significantly higher lidocaine concentration in muscle tissue than commercially available ZTlido (p = 0.008). These results indicate that SP-103 5.4% is highly effective in delivering lidocaine into muscle tissue in areas of localized pain for the treatment of musculoskeletal pain disorders (e.g., lower back pain)."

Journal • Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Scilex Holding Company Announces Issuance of New Patent in the U.S. for Its Lead Commercial Product ZTlido (lidocaine topical system) for a Method of Relieving Pain Through the Application of a Lidocaine-Containing Patch (Yahoo Finance) - "Scilex Holding Company...today announced that the U.S. Patent and Trademark Office has issued a new patent, No. 11,793,766 (the 'Patent'), further strengthening the Company’s intellectual property position and coverage for its lead commercial product, ZTlido® (lidocaine topical system) 1.8%. The Patent...covers a method of relieving pain through the application of a lidocaine-containing patch."

Patent • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Generates Record Monthly Revenue In October 2023 And Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The One Month Ended October 2023, And Year-To-Date Through October 31, 2023, Based On Currently Available Information (Yahoo Finance) - "Record ZTlido gross sales for October 2023 were in the range of $14.5 million to $15.5 million with record year-to-date gross sales through October 2023 in the range of $110.0 million to $120.0 million, compared to $74.8 million for year-to-date through October 2022, representing growth in the range of 47% to 60%. Full year gross sales for ZTlido in 2022 were $96.0 million."

Sales • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain