Scilex Holding Company Announces Publication on GLOPERBA® Dosing Adjustments in Peer-Review Journal

Rhea-AI Summary

Scilex Holding Company (SCLX) announced a publication highlighting GLOPERBA's dosing adjustments in a peer-reviewed journal. GLOPERBA is the first liquid oral colchicine for gout flare prophylaxis, enabling precision dosing for patients with renal impairment. The study reveals that patients with renal issues taking standard colchicine formulations often receive sub-optimal or excessive doses. The research demonstrates that GLOPERBA's liquid format allows for more precise dosing: 0.48 mg for moderate renal impairment and 0.3 mg for severe renal impairment, leading to better therapeutic outcomes. This is particularly significant as over 70% of gout patients have comorbid conditions requiring dose adjustments.

Positive

• GLOPERBA is the first and only liquid oral colchicine allowing precision dosing for gout patients
• Research demonstrates improved safety and optimal therapeutic levels with GLOPERBA's precise dosing capabilities
• Addresses a significant market need with 70% of gout patients having comorbid conditions requiring dose adjustments
• Publication in peer-reviewed journal validates the clinical importance of the dosing approach

Negative

• None.

Insights

Pharmaceutical Industry Analyst

Publication validates GLOPERBA's precision dosing advantage for gout patients with renal impairment, potentially expanding its clinical adoption.

Scilex's announcement regarding the peer-reviewed publication on GLOPERBA dosing adjustments represents a meaningful clinical validation for their liquid colchicine formulation. The publication provides evidence-based guidance for precision dosing in patients with renal impairment—a critical advantage over traditional solid colchicine formulations.

This development is particularly significant considering that over 70% of gout patients have comorbidities that may require dose adjustments. The pharmacokinetic model data revealed that patients with renal impairment taking solid colchicine formulations often receive either sub-therapeutic or potentially toxic doses.

GLOPERBA's liquid formulation enables precise dosing adjustments (0.48 mg for moderate renal impairment and 0.3 mg for severe renal impairment), allowing patients to maintain optimal therapeutic levels while minimizing side effects. This represents a substantial clinical advantage in a specific but sizeable patient population.

The endorsement from Dr. Michael Pillinger, a respected rheumatology expert from NYU, adds credibility to these findings. The publication could drive increased clinical adoption of GLOPERBA among nephrologists and rheumatologists treating the substantial subset of gout patients with kidney dysfunction.

For Scilex, this scientific validation differentiates GLOPERBA in the competitive gout medication landscape and could accelerate its market penetration in this specialized niche. While not announcing direct financial impact, this publication strengthens GLOPERBA's clinical positioning and supports its commercial potential within Scilex's non-opioid pain management portfolio.

PALO ALTO, Calif., June 05, 2025 (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 and neurodegenerative and cardiometabolic disease, today announced a publication on GLOPERBA^® dosing adjustments in peer-review journal.

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, allowing for precision dosing and reduction of daily dose in patients with severe renal impairment. Over 70% of gout patients have comorbid conditions that may require dose adjustments. GLOPERBA^® is currently manufactured in the U.S.

Patients receiving the standard prophylaxis dose of colchicine for gout flares are at increased risk for developing toxicity if there are pre-existing renal impairment or drug–drug interactions. Guidelines recommend exercising caution, deferring dose adjustment to the clinician’s discretion.

Analysis of pharmacokinetic model data demonstrated that most patients with renal impairment taking colchicine solid dosage formulations will be below or above therapeutic levels, exposing them to potential side effects. However, more precise dosing with colchicine oral solution of 0.48 mg (4 mL) for moderate renal impairment and 0.3 mg (2.5 mL) for severe renal impairment is associated with optimal levels within therapeutic widow and greater safety.

“This important publication will provide much needed data to guide clinical dosing of colchicine in patients with gout and chronic renal failure.” – said Michael H. Pillinger, MD, Professor of Medicine and Biochemistry and Molecular Pharmacology, Director of Rheumatology Training, NYU Clinical and Translational Science Institute.

Link to the article: https://link.springer.com/article/10.1007/s40744-025-00772-8

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

For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com

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 and neurodegenerative and cardiometabolic disease. 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) 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.

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 was 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 acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been 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.

Scilex Holding Company is headquartered in Palo Alto, California.

About Semnur Pharmaceuticals, Inc.

Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly-owned subsidiary of Scilex, is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, 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

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 a publication on GLOPERBA^® dosing adjustments in peer-review journal.

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: Scilex’s ability to remain in compliance with the Nasdaq continued listing requirements and to maintain the listing of the Company’s securities thereon; Scilex’s ability to develop and commercialize treatments for obesity, neurodegenerative, and cardiometabolic disease; 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, 2024 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, 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 use the registered trademark by Scilex Holding Company.

ELYXYB^® is a registered trademark owned by Scilex Holding Company.

All other trademarks are the property of their respective owners.

© 2025 Scilex Holding Company All Rights Reserved.

FAQ

What is GLOPERBA and how is it different from other gout medications?

GLOPERBA is the first and only liquid oral colchicine for gout flare prevention, enabling precise dosing adjustments for patients with kidney problems, unlike traditional solid formulations.

What are the recommended GLOPERBA dosing adjustments for patients with kidney problems?

The study recommends 0.48 mg (4 mL) for moderate renal impairment and 0.3 mg (2.5 mL) for severe renal impairment to achieve optimal therapeutic levels.

Why is SCLX's GLOPERBA significant for gout treatment?

GLOPERBA addresses a crucial need as over 70% of gout patients have other health conditions requiring dose adjustments, and its liquid form allows for more precise dosing than traditional tablets.

What clinical advantages does GLOPERBA offer compared to standard colchicine?

GLOPERBA's liquid formulation enables more precise dosing, potentially reducing toxicity risks and maintaining optimal therapeutic levels for patients with kidney problems.

How does the new SCLX publication impact GLOPERBA's clinical use?

The peer-reviewed publication provides important data to guide clinical dosing of colchicine specifically for patients with gout and chronic renal failure.