Scilex Holding Company Announces Seeking Approval from the FDA for Modification of the Gloperba® Label to Provide Specific Dosing Guidance for Patients with Renal Impairment and Other Circumstances Where Dose Adjustment is Needed

Rhea-AI Summary

Scilex Holding Company (SCLX) seeks FDA approval to modify Gloperba® label for dosing flexibility, targeting gout patients with renal impairment. The market potential is significant with increasing gout cases and unmet needs.

Pharmaceutical Market Analyst

The move by Scilex Holding Company to seek FDA approval for label modification of Gloperba® is a strategic step that could potentially increase the drug's market share within the gout treatment space. The emphasis on dosing flexibility and specific guidance for patients with renal impairment addresses a critical gap in patient care. Given that a significant portion of the gout patient population suffers from comorbid conditions such as renal or hepatic impairment, this label expansion could lead to increased adoption of Gloperba® among healthcare providers.

Furthermore, the market potential for gout treatments is substantial, with projections indicating a growth to $2.0 billion by 2028 in the United States. Scilex's focus on non-opioid pain management products, including Gloperba®, positions the company favorably in a market that is increasingly wary of opioid use. The introduction of a liquid formulation of colchicine is innovative and it could become a differentiator for Scilex, potentially impacting their stock positively if the FDA approval is granted and the subsequent product launch is successful.

Healthcare Provider

From a clinical perspective, the introduction of a liquid formulation of colchicine, such as Gloperba®, is significant. It allows for more precise dosing, which is particularly beneficial for patients with varying degrees of renal impairment—a common issue among those with gout. Precision dosing can lead to better patient outcomes by reducing the risk of toxicity, which is a concern with colchicine, especially considering that over 17% of patients experience severe gastrointestinal side effects.

The American College of Rheumatology's guidelines highlighting the need for such dosing flexibility underscores the clinical importance of this development. If the FDA approves the label modification, it could lead to a paradigm shift in how gout is managed, especially in patients with renal challenges and may influence prescribing habits in favor of Gloperba® over traditional tablet or capsule forms of colchicine.

Health Economics Expert

Considering the economic implications, Scilex's Gloperba® could offer cost-saving advantages to the healthcare system by potentially reducing the incidence of colchicine toxicity and associated hospitalizations. For patients, the extended duration of a single bottle due to lower dosing requirements translates to potential cost savings and convenience. This aspect should not be underestimated as it can improve medication adherence and overall treatment satisfaction.

However, the long-term success of Gloperba® will depend on various factors, including competitive pricing, insurance coverage and the ability of Scilex to effectively communicate the benefits of their product to both patients and providers. The cost-effectiveness of Gloperba® compared to traditional colchicine tablets or capsules will be a critical factor in its market penetration and, by extension, its impact on Scilex's financial performance.

• Seek approval from the FDA for the modification of the Gloperba^® label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below:
  • Patients with mild or moderate renal or hepatic impairment should be considered for dose adjustment.
  • For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
  • For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
• 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 United States 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 could be potential target population for Gloperba^®3
• Over 17% of gout patients on colchicine have experienced severe gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by Gloperba^®4

PALO ALTO, Calif., March 20, 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 it will seek approval from the FDA for the modification of the Gloperba^® label to include its ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below:

• Patients with mild or moderate renal or hepatic impairment should be considered for dose adjustment.
• For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
• For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
  

A recent market research study among rheumatologists 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

Scilex expects to launch Gloperba^® in the first half of 2024. 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. Approximately 70% of gout patients have chronic kidney disease stage 2 and many suffer from gastrointestinal sensitivity, necessitating a lower dose of colchicine than the standard 0.6 mg tablet or capsule³. Gloperba^® is the first and only liquid colchicine formulation that allows healthcare providers to prescribe precision dosing in these at-risk patient populations, and thereby help mitigate against severe toxicity in patients. Healthcare providers can now safely and effectively manage these patients at doses below 0.6 mg once or twice daily, which is the standard dose for prophylaxis. For patients who are treated at doses lower than 0.6 mg, the 150 ml bottle of Gloperba® is expected to last longer than 30 days, delivering additional value to patients.

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

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

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

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

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.

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^®, estimates for the launch pricing of Gloperba^®, the belief that Scilex is well-positioned to market and distribute Gloperba^®, Scilex’s expectations for Gloperba^® to be the first liquid oral version of colchicine formulation allowing providers to prescribe precision dosing, Scilex’s expectations for Gloperba^® to last more than 30 days in patients who are treated with doses lower than 0.6 mg, Scilex’s expectation to launch Gloperba^® in the first half of 2024 , each parties’ releases of claims arising from the captioned patent infringement lawsuit, the granting of the non-exclusive license and FDA’s approval for the modification of the Gloperba^® label and plans to initiate a Phase 2 clinical trial in 2024 for SP-104.

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, 2022 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, 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

Reference:

1) https://jamanetwork.com/journals/jama/fullarticle/2787544#:~:text=How%20Common%20Is%20Gout%3F,%25%20of%20the%20adult%20population

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 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.

© 2024 Scilex Holding Company All Rights Reserved.

FAQ

What is the purpose of Scilex Holding Company (SCLX) seeking FDA approval for Gloperba® label modification?

Scilex aims to include dosing flexibility in the Gloperba® label to cater to patients with renal impairment.

Who is the target population for Gloperba® after the label modification?

Patients with mild, moderate, or severe renal impairment, and those undergoing dialysis.

What is the unique selling point of Gloperba® in the gout treatment market?

Gloperba® is the first and only liquid oral version of colchicine for prophylaxis of gout flares, offering precision dosing.

What percentage of gout patients have comorbid conditions requiring dose adjustments?

Over 70% of gout patients may need dose adjustments, making them potential target population for Gloperba®.

What is the expected launch timeline for Gloperba®?

Scilex anticipates launching Gloperba® in the first half of 2024.