Scilex Holding Company Announces Presentation of Data 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 (SCLX) announced a data presentation at the 2024 American College of Rheumatology Convergence conference in Washington, D.C. The presentation focuses on GLOPERBA®, their liquid colchicine formulation for gout patients. The data discusses pharmacokinetic model-derived dosing for patients with moderate and severe chronic kidney disease. GLOPERBA® is notable as the first and only liquid colchicine offering precision dosing, including reduced daily doses (0.3 mg/day) for patients with severe renal impairment, following a recent FDA label update.
Scilex Holding Company (SCLX) ha annunciato una presentazione dati durante il convegno della American College of Rheumatology Convergence 2024 a Washington, D.C. La presentazione si concentra su GLOPERBA®, la loro formulazione liquida di colchicina per pazienti affetti da gotta. I dati discutono il dosaggio derivato da modelli farmacocinetici per pazienti con malattia renale cronica moderata e grave. GLOPERBA® è notevole in quanto rappresenta la prima e unica colchicina liquida che offre un dosaggio preciso, inclusi dosaggi giornalieri ridotti (0,3 mg/giorno) per pazienti con grave compromissione renale, in seguito a un recente aggiornamento dell'etichetta da parte della FDA.
Scilex Holding Company (SCLX) anunció una presentación de datos en la conferencia Convergencia 2024 de la American College of Rheumatology en Washington, D.C. La presentación se centra en GLOPERBA®, su formulación líquida de colchicina para pacientes con gota. Los datos abordan el dosaje derivado de modelos farmacocinéticos para pacientes con enfermedad renal crónica moderada y severa. GLOPERBA® es notable por ser la primera y única colchicina líquida que ofrece dosificación precisa, incluidos dosis diarias reducidas (0,3 mg/día) para pacientes con grave deterioro renal, tras una reciente actualización de la etiqueta por parte de la FDA.
Scilex Holding Company (SCLX)는 워싱턴 D.C.에서 열리는 2024년 미국 류마티스학회 컨버전스 회의에서 데이터 발표를 알렸습니다. 이 발표는 요산 환자를 위한 액체 콜히친 제제인 GLOPERBA®에 초점을 맞추고 있습니다. 데이터는 중증 및 중등도 만성 신장 질환 환자를 위한 약물 동태 모델에 기반한 용량에 대해 논의합니다. GLOPERBA®는 최근 FDA 라벨 업데이트에 따라 중증 신부전 환자를 위한 감소된 일일 용량(0.3 mg/일)을 포함하여 정밀한 용량을 제공하는 첫 번째이자 유일한 액체 콜히친으로 주목받고 있습니다.
Scilex Holding Company (SCLX) a annoncé une présentation de données lors de la conférence Convergence 2024 du American College of Rheumatology à Washington, D.C. La présentation se concentre sur GLOPERBA®, leur formulation liquide de colchicine pour les patients atteints de goutte. Les données discutent du dosage dérivé de modèles pharmacocinétiques pour les patients atteints de maladie rénale chronique modérée et sévère. GLOPERBA® est remarquable en tant que première et unique colchicine liquide offrant un dosage précis, y compris des doses journalières réduites (0,3 mg/jour) pour les patients atteints d'insuffisance rénale sévère, suite à une mise à jour récente de l'étiquette par la FDA.
Scilex Holding Company (SCLX) hat eine Datenpräsentation auf der Konferenz der American College of Rheumatology Convergence 2024 in Washington, D.C. angekündigt. Die Präsentation konzentriert sich auf GLOPERBA®, ihre flüssige Colchicin-Formulierung für Gichtpatienten. Die Daten erörtert dosing, das von pharmakokinetischen Modellen für Patienten mit moderater und schwerer chronischer Nierenerkrankung abgeleitet wurde. GLOPERBA® ist bemerkenswert, da es die erste und einzige flüssige Colchicin ist, die eine präzise Dosisierung bietet, einschließlich reduzierter Tagesdosen (0,3 mg/Tag) für Patienten mit schwerer Niereninsuffizienz, nach einem aktuellen Update des FDA-Labels.
- FDA approval received for updated GLOPERBA® label with new dosing adjustments
- GLOPERBA® is the only liquid colchicine formulation in the market offering precision dosing
- Product differentiator: Unique ability to reduce doses for severe renal impairment patients
- None.
PALO ALTO, Calif. , Nov. 15, 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 presentation of data 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.
A PDF accompanying this announcement is available at http://ml.globenewswire.com/Resource/Download/f5fbf217-49d5-426d-bae2-028acefb4dd3
For more information on Scilex Holding Company, refer to www.scilexholding.com
For more information on Semnur Pharmaceuticals, 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. 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)
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.
For more information on Scilex Holding Company, refer to www.scilexholding.com
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 lead program, 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.
For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com
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
What is the new dosing adjustment for GLOPERBA (SCLX) in severe renal impairment patients?
When is Scilex (SCLX) presenting GLOPERBA data at the 2024 ACR Conference?
What makes GLOPERBA (SCLX) different from other colchicine medications?
