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Scilex Holding Company Announces New Out-of-Pocket Costs for Commercially Insured Patients

Scilex Holding Company Announces New Out-of-Pocket Costs for Commercially Insured Patients

Scilex控股公司宣佈爲商業保險患者提供新的自付費用
GlobeNewswire ·  03/21 09:30

PALO ALTO, Calif., March  21, 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 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, and gout flare prophylaxis product, Gloperba, which is expected to launch in the first half of 2024. 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.

加利福尼亞州帕洛阿爾託,2024年3月21日(GLOBE NEWSWIRE)——專注於收購、開發和商業化用於治療急慢性疼痛的非阿片類疼痛管理產品的創新型創收公司Scilex控股公司(納斯達克股票代碼:SCLX,“Scilex” 或 “公司”)今天宣佈,其商業保險患者的產品組合的自付費用預計將受到限制每月25美元,某些符合條件的患者支付的費用低至0美元。這適用於該公司的帶狀皰疹後遺神經痛止痛產品ztLido、偏頭痛產品ELYXYB和痛風發作預防產品Gloperba,後者預計將於2024年上半年推出。Scilex已進行了大量投資,以提高患者的可負擔性和獲得其產品的可及性,並將繼續在公司向患者提供非阿片類藥物疼痛管理產品的承諾基礎上再接再厲。

Scilex has been working with its co-pay savings card adjudicators to resolve the recent breakdown of processing of insurance claims by Change Healthcare, following a cyber-attack on Change Healthcare. Scilex is aware of the impact this disruption has had on its patients and customers and has worked diligently to resolve the issue. Starting today, co-pay savings card processing for ZTlido is expected to be restored to normal operations.

在Change Healthcare遭到網絡攻擊之後,Scilex一直在與其自付儲蓄卡裁定人合作,以解決Change Healthcare最近發生的保險索賠處理中斷的問題。Scilex意識到這種中斷對其患者和客戶的影響,並一直在努力解決這個問題。從今天開始,預計ZTLido的自付儲蓄卡處理將恢復正常運營。

Scilex believes that high deductibles and copays shouldn't prevent anyone from receiving the medications they need. Scilex co-pay programs is designed to help patients reduce their co-pays and out-of-pocket costs for their medication. Our program partners with various assistance programs to help make a patient's medication affordable.

Scilex認爲,高額的免賠額和自付額不應阻止任何人獲得所需的藥物。Scilex自付計劃旨在幫助患者減少自付費用和藥物自付費用。我們的計劃與各種援助計劃合作,以幫助患者負擔得起藥物。

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

有關 Scilex 控股公司的更多信息,請參閱 www.scilexholding.com

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

有關 zTLido® 的更多信息,包括完整的處方信息,請參閱 www.ztlido.com

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

有關 ELYXYB® 的更多信息,包括完整的處方信息,請參閱 www.elyxyb.com

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

有關 Gloperba® 的更多信息,包括完整的處方信息,請參閱 www.gloperba.com

About Scilex Holding Company

關於 Scilex 控股公司

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 the first half of 2024.

Scilex Holding Company是一家創新的創收公司,專注於收購、開發和商業化用於治療急性和慢性疼痛的非阿片類疼痛管理產品。Scilex以非阿片類藥物治療急慢性疼痛患者的適應症爲目標,致力於改善和改善患者預後,以未得到滿足的高需求和巨大的市場機會爲目標。Scilex的商業產品包括:(i)ztLido(利多卡因局部用藥系統)1.8%,這是一種經美國食品藥品監督管理局(“FDA”)批准的處方利多卡因局部用藥物,用於緩解與帶狀皰疹後神經痛相關的神經病理性疼痛;(ii)ELYXYB,一種潛在的一線治療方法和只有經美國食品藥品管理局批准的用於急性治療成人偏頭痛的即用型口服溶液,無論有無先兆;以及(iii)Gloperba,抗痛風藥物秋水仙鹼的第一個也是唯一的液體口服版本適用於預防成人痛風發作,預計將於2024年上半年推出。

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 has 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 chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has 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 and a Phase 2 clinical trial is expected to commence in 2024.

此外,Scilex還有三種候選產品:(i)SP-102(10 mg,地塞米松磷酸鈉粘性凝膠)(“SEMDEXA” 或 “SP-102”),這是一種廣泛用於硬膜外注射的皮質類固醇的新型粘性凝膠製劑,用於治療腰骶神經根痛或坐骨神經痛,Scilex已經完成了3期研究,已於2017年獲得美國食品藥品管理局的Fast Track地位;(ii)SP-103(利多卡因外用系統)5.4%(“SP-103”),ZTLido的下一代三強度配方,用於治療慢性頸部疼痛,Scilex最近已將其用於治療慢性頸部疼痛完成了腰痛的二期試驗。SP-103 已獲得美國食品藥品管理局在腰痛方面的快速通道地位;以及 (iii) SP-104(4.5 mg,低劑量鹽酸納曲酮延遲釋放膠囊)(“SP-104”),一種用於治療纖維肌痛的新型低劑量延遲釋放鹽酸納曲酮,其1期試驗已於2022年第二季度完成,2期臨床試驗預計將於2024年開始。

Scilex Holding Company is headquartered in Palo Alto, California.

Scilex 控股公司總部位於加利福尼亞州帕洛阿爾託。

Forward-Looking Statements

前瞻性陳述

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 expected out-of-pocket costs for commercially insured patients, the expectation that co-pay savings card processing for ZTlido will be restored, Scilex's expectation to launch Gloperba in the first half of 2024 and plans to initiate a Phase 2 clinical trial in 2024 for SP-104.

根據1995年《私人證券訴訟改革法》第21E條的安全港條款,本新聞稿以及就本新聞稿中討論的事項在任何演講或會議期間發表的任何聲明均包含與Scilex及其子公司相關的前瞻性陳述,並受風險和不確定性的影響,可能導致實際業績與預期存在重大差異。前瞻性陳述包括有關商業保險患者的預期自付費用、恢復ZTLido自付儲蓄卡處理的預期、Scilex預計將在2024年上半年推出Gloperba以及計劃在2024年啓動針對SP-104 的2期臨床試驗的陳述。

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, 2023, 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.

可能導致Scilex的實際業績與我們的前瞻性陳述中表達的業績存在重大不利差異的風險和不確定性包括但不限於:與交易市場的不可預測性相關的風險以及是否會爲Scilex的普通股建立市場;總體經濟、政治和商業狀況;與 COVID-19(和其他類似干擾)相關的風險;Scilex開發的潛在候選產品可能無法通過臨床進展的風險需要開發或接收監管部門在預期的時間表內或完全獲得批准;與Scilex候選產品的監管路徑不確定性相關的風險;Scilex無法成功推銷其候選產品或獲得市場認可的風險;Scilex的候選產品可能對患者沒有好處或成功商業化的風險;Scilex高估了目標患者群體的規模、他們嘗試新療法的意願的風險醫生願意開這些療法;風險SP-102、SP-103 或 SP-104 的試驗和研究結果可能不成功或反映出積極的結果;SP-102(SEMDEXA)、SP-103 或 SP-104 的臨床和研究者發起的先前試驗結果可能無法複製的風險;監管和知識產權風險;以及不時顯示的其他風險和不確定性以及Scilex向美國證券交易委員會提交的最新定期報告(包括Scilex的年度報告)中描述的其他風險截至2023年12月31日止年度的10-K表報告,包括這些文件中列出的風險因素.提醒投資者不要過分依賴這些前瞻性陳述,這些陳述僅代表截至本新聞稿發佈之日,除非法律要求,否則Scilex沒有義務更新本新聞稿中的任何前瞻性陳述。

Contacts:

聯繫人:

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

投資者和媒體
Scilex 控股公司
聖安東尼奧路 960 號
加利福尼亞州帕洛阿爾託 94303
辦公室:(650) 516-4310

Email: investorrelations@scilexholding.com

電子郵件:investorrelations@scilexholding.com

Website:

網站:

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.

SEMDEXA(SP-102)是Scilex Holding Company的全資子公司Semnur Pharmicals, Inc. 擁有的商標。美國食品和藥物管理局計劃對專有名稱進行審查。

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

ztLido是Scilex Holding Company的全資子公司Scilex Pharmicals Inc. 擁有的註冊商標。

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

Gloperba 獲得 Scilex Holding Company 獨家、可轉讓的使用註冊商標的許可。

ELYXYB is a registered trademark owned by Scilex Holding Company.

ELYXYB 是 Scilex 控股公司擁有的註冊商標。

All other trademarks are the property of their respective owners.

所有其他商標均爲其各自所有者的財產。

2024 Scilex Holding Company All Rights Reserved.

2024 Scilex 控股公司版權所有

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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