Scilex Holding Company Announces FDA Final Approval to Precision Dosing for GLOPERBA® Label
Scilex Holding Company (Nasdaq: SCLX) announced FDA approval for label updates to GLOPERBA®, the first and only liquid oral version of colchicine for gout flare prophylaxis in adults. This approval allows for precision dosing, particularly beneficial for the 70% of gout patients with chronic kidney disease or gastrointestinal sensitivity who may require lower doses than the standard 0.6 mg tablet.
GLOPERBA® enables dosage reduction to 0.3 mg/day for patients with severe renal impairment. The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028. A recent market study showed high interest among rheumatologists in GLOPERBA® for at-risk patient populations needing lower precision dosing to mitigate colchicine toxicity risk.
Scilex Holding Company (Nasdaq: SCLX) ha annunciato l'approvazione da parte della FDA per aggiornamenti dell'etichetta di GLOPERBA®, la prima e unica versione liquida orale della colchicina per la profilassi delle crisi di gotta negli adulti. Questa approvazione consente un dosing preciso, particolarmente utile per il 70% dei pazienti con gotta che soffrono di malattia renale cronica o di sensibilità gastrointestinale, che potrebbero avere bisogno di dosi inferiori rispetto al normale compresse da 0,6 mg.
GLOPERBA® consente una riduzione del dosaggio a 0,3 mg/giorno per i pazienti con grave compromissione renale. Si prevede che il mercato del trattamento per la gotta raggiunga 2,0 miliardi di dollari negli Stati Uniti entro il 2028. Un recente studio di mercato ha rivelato un alto interesse tra i reumatologi per GLOPERBA® nelle popolazioni di pazienti a rischio che necessitano di un dosaggio preciso inferiore per mitigare il rischio di tossicità della colchicina.
Scilex Holding Company (Nasdaq: SCLX) anunció la aprobación de la FDA para actualizaciones de la etiqueta de GLOPERBA®, la primera y única versión líquida oral de colchicina para la prevención de crisis de gota en adultos. Esta aprobación permite una dosis precisa, especialmente beneficiosa para el 70% de los pacientes con gota que padecen enfermedad renal crónica o sensibilidad gastrointestinal, quienes pueden requerir dosis más bajas que la tableta estándar de 0,6 mg.
GLOPERBA® permite una reducción de la dosis a 0,3 mg/día para pacientes con grave deterioro renal. Se proyecta que el mercado de tratamiento de la gota alcance $2.0 mil millones en EE. UU. para 2028. Un estudio reciente del mercado mostró un alto interés entre los reumatólogos en GLOPERBA® para poblaciones de pacientes en riesgo que necesitan un dosificación más precisa para mitigar el riesgo de toxicidad de la colchicina.
Scilex Holding Company (Nasdaq: SCLX)는 성인 통풍 발작 예방을 위한 콜히친의 첫 번째이자 유일한 액상 구강 버전인 GLOPERBA®의 라벨 업데이트에 대해 FDA 승인을 발표했습니다. 이 승인은 정확한 용량 조절을 가능하게 하며, 특히 만성 신장 질환이나 위장 민감성을 가진 70%의 통풍 환자에게 유익하며, 이들은 표준 0.6 mg 정제보다 낮은 용량이 필요할 수 있습니다.
GLOPERBA®는 중증 신장 손상이 있는 환자를 위해 하루 0.3 mg으로 용량을 줄일 수 있도록 합니다. 통풍 치료 시장은 2028년까지 미국에서 20억 달러에 이를 것으로 예상됩니다. 최근 시장 조사에서 콜히친 독성 위험을 완화하기 위해 낮은 정밀 용량이 필요한 위험군 환자를 위한 GLOPERBA®에 대한 류마티스 전문의들의 높은 관심이 나타났습니다.
Scilex Holding Company (Nasdaq: SCLX) a annoncé l'approbation par la FDA de mises à jour d'étiquettes pour GLOPERBA®, la première et unique version liquide orale de colchicine pour la prophylaxie des accès de goutte chez les adultes. Cette approbation permet un dosage précis, particulièrement bénéfique pour les 70 % des patients souffrant de goutte ayant une maladie rénale chronique ou une sensibilité gastro-intestinale qui peuvent nécessiter des doses plus faibles que le comprimé standard de 0,6 mg.
GLOPERBA® permet une réduction de la dose à 0,3 mg/jour pour les patients souffrant d'insuffisance rénale sévère. Le marché du traitement de la goutte devrait atteindre 2,0 milliards de dollars aux États-Unis d'ici 2028. Une étude de marché récente a montré un grand intérêt parmi les rhumatologues pour GLOPERBA® pour les populations de patients à risque nécessitant une dose précise plus faible afin de réduire le risque de toxicité de la colchicine.
Scilex Holding Company (Nasdaq: SCLX) hat die FDA-Zulassung für Aktualisierungen des Etiketts von GLOPERBA® bekannt gegeben, der ersten und einzigen flüssigen oralen Version von Colchicin zur Prophylaxe von Gichtanfällen bei Erwachsenen. Diese Genehmigung ermöglicht präzise Dosierung, was insbesondere für die 70% der Gichtpatienten mit chronischer Nierenerkrankung oder gastrointestinaler Überempfindlichkeit von Vorteil ist, die möglicherweise niedrigere Dosen als die Standardtablette von 0,6 mg benötigen.
GLOPERBA® ermöglicht eine Reduzierung der Dosierung auf 0,3 mg/Tag für Patienten mit schwerer Niereninsuffizienz. Es wird prognostiziert, dass der Markt für Gichtbehandlungen bis 2028 in den USA 2,0 Milliarden USD erreichen wird. Eine aktuelle Marktstudie zeigte ein hohes Interesse unter Rheumatologen an GLOPERBA® für gefährdete Patientengruppen, die eine niedrigere präzise Dosierung benötigen, um das Risiko der Colchicintoxizität zu verringern.
- FDA approval for precision dosing label updates to GLOPERBA®
- First and only liquid oral colchicine for gout flare prophylaxis
- Allows for flexible dosing, beneficial for 70% of gout patients with comorbidities
- Projected $2.0 billion U.S. gout treatment market by 2028
- High interest from rheumatologists in GLOPERBA® for at-risk patients
- to prophylaxis of gout flares, not for acute treatment
- Safety and effectiveness for acute gout flare treatment during prophylaxis not studied
- Maximum recommended dose of 1.2 mg/day may limit usage in some patients
Insights
The FDA's approval for precision dosing of GLOPERBA® is a significant development for Scilex Holding Company. This liquid formulation of colchicine addresses a critical unmet need in gout treatment, particularly for patients with comorbidities requiring dose adjustments. With an estimated
The ability to provide flexible dosing, especially for patients with severe renal impairment, gives GLOPERBA® a competitive edge over traditional colchicine tablets. This unique selling proposition could drive adoption among rheumatologists and potentially lead to increased market penetration. However, the impact on Scilex's revenue will depend on pricing strategy and insurance coverage, which are not disclosed in the announcement.
The approval of GLOPERBA®'s precision dosing is a medical breakthrough in gout management. It addresses the crucial issue of toxicity in at-risk populations, particularly the
This development aligns with the American College of Rheumatology guidelines, indicating strong potential for widespread adoption in clinical practice. The extended usage period of over 30 days per bottle for lower doses adds value for patients and could improve treatment adherence. However, long-term studies on the efficacy of these lower doses in preventing gout flares will be important for sustained market success.
- FDA Final Approval to Precision Dosing for GLOPERBA® Label.
- We believe GLOPERBA® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
- Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. According to data gathered by Evaluate Pharma, the gout treatment market is projected to reach
$2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.2 - Over
70% of gout patients have comorbid conditions that may require dose adjustments, and such patients are a potential target population for GLOPERBA®.3 - Over
17% of gout patients on colchicine experienced severe gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by GLOPERBA®.4 - Unlike other colchicine formulations, GLOPERBA® allows reduction of daily dose in patients with severe renal impairment (0.3 mg/day).
PALO ALTO, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “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 FDA approval of a Supplemental New Drug Application for Label Updates to GLOPERBA®.
GLOPERBA® is the only FDA-approved liquid formulation of colchicine for the prophylaxis of acute gout flares. Over
A recent market research study among rheumatologists conducted by Scilex revealed a high degree of interest in Gloperba® as a liquid colchicine formulation designed for precision dosing.5 Specifically, clinicians using colchicine for prophylaxis of gout flares in adults indicated a strong likelihood to use GLOPERBA® instead of tablets/capsules in certain at-risk patient populations who have a clinical need for lowered precision dosing to mitigate the risk of colchicine toxicity. Notably, the American College of Rheumatology (ACR) guidelines also reflect this need.6
INDICATIONS AND USAGE
- GLOPERBA® (colchicine USP) Oral Solution is indicated for prophylaxis of gout flares in adults.
- Limitations of use: The safety and effectiveness of GLOPERBA® for acute treatment of gout flares during prophylaxis has not been studied. GLOPERBA® is not an analgesic medication and should not be used to treat pain from other causes.
DOSAGE AND ADMINISTRATION
- Gout Prophylaxis
- The recommended dosage of GLOPERBA® (0.12 MG/ML OF COLCHICINE ORAL SOLUTION) for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose is 1.2 mg/day.
- The recommended dosage of GLOPERBA® (0.12 MG/ML OF COLCHICINE ORAL SOLUTION) for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose is 1.2 mg/day.
| Colchicine mg to Gloperba mL Conversion Table | ||
| Colchicine (mg) | Gloperba (mL) | |
| 0.3 mg | 2.5 mL | |
| 0.6 mg | 5 mL | |
| 1.2 mg | 10 mL | |
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- GLOPERBA® is administered orally, without regard to meals.
- Prophylactic therapy may be beneficial for at least the first six months of uric acid-lowering therapy.
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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 estimates for the gout treatment market and affected patient population, estimates for potential demand for Gloperba, the belief that Scilex is well-positioned to market and distribute Gloperba, Scilex’s expectations for Gloperba to be the first liquid colchicine formulation allowing providers to prescribe precision dosing and Scilex’s expectations for Gloperba to last more than 30 days in patients who are treated with lower doses than 0.6 mg.
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.
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Reference
1) https://jamanetwork.com/journals/jama/fullarticle/2787544#:~:text=How%20Common%20Is%20Gout%3F,%
2) Evaluate Pharma data
3) Comorbidities of Gout and Hyperuricemia in the US General Population: NHANES 2007-2008
4) Stewart et al. Arthritis Research & Therapy (2020) 22:28; https://doi.org/10.1186/s13075-020-2120-7
5) Scilex market research study of US rheumatologists, Nov-Dec 2023
6) Khanna D, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 2: Therapy and Anti-inflammatory Prophylaxis of Acute Gouty Arthritis. Arthritis Care & Research. Vol. 64, No. 10, October 2012, pp 1447–1461
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.
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FAQ
What is GLOPERBA® and what did the FDA approve for it?
How does GLOPERBA® (SCLX) benefit patients with kidney disease?
What is the projected market size for gout treatment in the U.S. by 2028?
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