Scilex Holding Company Announces Acceptance of Presentation at the 2024 American College of Rheumatology Convergence Conference to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 14 – 19, 2024
Scilex Holding Company (Nasdaq: SCLX), a company focused on non-opioid pain management products, announced the acceptance of a presentation at the 2024 American College of Rheumatology Convergence conference. The presentation, titled 'Prophylaxis of Gout Flares in Patients with Renal Impairment: Dosing Adjustments with Colchicine Oral Solution Informed by a Pharmacokinetic Model', will be held on November 16, 2024.
The presentation will focus on GLOPERBA®, the first liquid formulation of colchicine, which offers precision dosing for at-risk gout patients. Scilex recently received FDA approval for an updated GLOPERBA® label, allowing for dosage adjustments in various clinical situations, including a reduced daily dose for patients with severe renal impairment.
Scilex Holding Company (Nasdaq: SCLX), un'azienda focalizzata su prodotti per la gestione del dolore non oppioidi, ha annunciato l'accettazione di una presentazione alla conferenza Convergence 2024 dell'American College of Rheumatology. La presentazione, intitolata 'Profilassi delle crisi gottee in pazienti con insufficienza renale: aggiustamenti del dosaggio con la soluzione orale di colchicina informati da un modello farmacocinetico', si terrà il 16 novembre 2024.
La presentazione si concentrerà su GLOPERBA®, la prima formulazione liquida di colchicina, che offre un dosaggio preciso per i pazienti a rischio di gotta. Scilex ha recentemente ricevuto l'approvazione della FDA per un'etichetta aggiornata di GLOPERBA®, che consente aggiustamenti del dosaggio in varie situazioni cliniche, inclusa una dose giornaliera ridotta per i pazienti con grave insufficienza renale.
Scilex Holding Company (Nasdaq: SCLX), una empresa enfocada en productos para el manejo del dolor no opioide, anunció la aceptación de una presentación en la conferencia Convergence 2024 del American College of Rheumatology. La presentación, titulada 'Profilaxis de los brotes de gota en pacientes con insuficiencia renal: ajustes de dosis con solución oral de colquicina informados por un modelo farmacocinético', se llevará a cabo el 16 de noviembre de 2024.
La presentación se centrará en GLOPERBA®, la primera formulación líquida de colquicina, que ofrece dosificación precisa para pacientes con riesgo de gota. Scilex recibió recientemente la aprobación de la FDA para una etiqueta actualizada de GLOPERBA®, permitiendo ajustes de dosificación en diversas situaciones clínicas, incluida una dosis diaria reducida para pacientes con insuficiencia renal severa.
Scilex Holding Company (Nasdaq: SCLX)는 비오피오이드 통증 관리 제품에 집중하는 회사로, 2024년 미국 류마티스 학회 컨버전스 회의에서 발표가 수락되었음을 발표했습니다. 발표 제목은 '신장 기능장애 환자의 통풍 발작 예방: 약리 동적 모델에 의해 알려진 콜키신 경구 용액의 용량 조정'이며, 2024년 11월 16일에 진행됩니다.
이 발표는 위험이 있는 통풍 환자를 위한 정밀한 용량 조정을 제공하는 콜키신의 첫 번째 액체 제형인 GLOPERBA®에 초점을 맞출 것입니다. Scilex는 최근 심각한 신장 기능장애 환자를 위한 일일 복용량을 줄이는 등의 다양한 임상 상황에서의 용량 조정을 허용하는 업데이트된 GLOPERBA® 레이블에 대해 FDA 승인을 받았습니다.
Scilex Holding Company (Nasdaq: SCLX), une entreprise axée sur des produits de gestion de la douleur non opioïdes, a annoncé l'acceptation d'une présentation lors de la conférence Convergence 2024 de l'American College of Rheumatology. La présentation, intitulée 'Prophylaxie des poussées de goutte chez les patients souffrant d'insuffisance rénale : ajustements posologiques avec une solution orale de colchicine informée par un modèle pharmacocinétique', aura lieu le 16 novembre 2024.
La présentation se concentrera sur GLOPERBA®, la première formulation liquide de colchicine, qui offre un dosage précis pour les patients à risque de goutte. Scilex a récemment obtenu l'approbation de la FDA pour une étiquette mise à jour de GLOPERBA®, permettant des ajustements de dosage dans diverses situations cliniques, y compris une dose journalière réduite pour les patients souffrant d'insuffisance rénale sévère.
Scilex Holding Company (Nasdaq: SCLX), ein Unternehmen, das sich auf nicht-opioide Schmerzmanagementprodukte konzentriert, gab bekannt, dass eine Präsentation auf der Konferenz Convergence 2024 des American College of Rheumatology angenommen wurde. Die Präsentation mit dem Titel 'Prophylaxe von Gichtanfällen bei Patienten mit Niereninsuffizienz: Dosisanpassungen mit einer oralen Kolchizinlösung, informiert durch ein pharmakokinetisches Modell', findet am 16. November 2024 statt.
Die Präsentation wird sich auf GLOPERBA® konzentrieren, die erste flüssige Formulierung von Kolchizin, die präzise Dosierung für gefährdete Gichtpatienten bietet. Scilex erhielt kürzlich die FDA-Zulassung für ein aktualisiertes GLOPERBA®-Label, das Dosisanpassungen in verschiedenen klinischen Situationen, einschließlich einer reduzierten Tagesdosis für Patienten mit schwerer Niereninsuffizienz, erlaubt.
- FDA approval for updated GLOPERBA® label, allowing for more precise dosing adjustments
- GLOPERBA® is the first and only liquid formulation of colchicine, offering precision dosing for at-risk gout patients
- Acceptance of presentation at a major rheumatology conference, potentially increasing visibility and credibility in the field
- None.
PALO ALTO, Calif., Sept. 05, 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 the acceptance of a presentation at the 2024 American College of Rheumatology Convergence conference to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 14 – 19, 2024.
Title: Prophylaxis of Gout Flares in Patients with Renal Impairment: Dosing Adjustments with Colchicine Oral Solution Informed by a Pharmacokinetic Model
Authors: Jaymin Shah, PhD, FCP; Elaine K. Chan, PharmD; Dmitri Lissin, MD
Presentation: Saturday, November 16, 2024, at 10:30 AM ET - 12:30 PM ET
- GLOPERBA® (colchicine oral solution) is the first and only liquid formulation of colchicine that offers precision dosing for at risk gout patients.
- Scilex recently received FDA approval for an updated GLOPERBA® label, which reflects dosing adjustments in various clinical situations. Unlike other colchicine formulations, GLOPERBA® allows reduction of daily dose in patients with severe renal impairment (0.3 mg/day).
- Data to be presented summarizes pharmacokinetic model derived dosing for at-risk moderate and severe chronic kidney disease patients who require lower precision dosing, not offered by other colchicine formulations of tablets and capsules currently available on the market.
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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. 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)
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)
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 Scilex’s expectations for Gloperba to be the first liquid colchicine formulation allowing providers to prescribe precision dosing and reducing daily dose in patients with severe renal impairment.
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; general economic, political and business conditions; 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, 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
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