Scilex Holding Company Sets Launch Price of $595 per 150ml bottle of Gloperba®, its First and Only Liquid Oral Version of the Anti-Gout Medicine Colchicine Indicated for the Prophylaxis of Painful Gout Flares in Adults; Expected Plans to Launch in the First Half of 2024

Rhea-AI Summary

Scilex Holding Company announces plans to launch Gloperba, the first liquid colchicine formulation for gout treatment, in 2024. The market potential is significant, with over 9.2 million affected individuals in the U.S. and a projected $2.0 billion market by 2028. Gloperba offers precision dosing for patients with comorbid conditions, potentially reducing severe side effects. Scilex's experience in commercialization positions them well for Gloperba's successful launch.

Insights

Pharmaceutical Market Analyst

The introduction of Gloperba® as the first FDA-approved liquid colchicine formulation for gout prophylaxis represents a significant innovation in the treatment of gout, particularly given the comorbidities such as chronic kidney disease and gastrointestinal sensitivity prevalent in over 70% of gout patients. The precision dosing capability of Gloperba® could address the unmet need for a tailored gout treatment that minimizes the risk of severe side effects and toxicity associated with standard colchicine tablets or capsules.

The projected growth of the gout treatment market to $2.0 billion by 2028 underscores the potential financial impact of Gloperba® on Scilex's revenue. With an established distribution network and a commercial team experienced in launching similar products, Scilex seems well-positioned to capitalize on this opportunity. However, the launch price of $595 per 150ml bottle could be a point of contention, especially in the current healthcare cost-conscious environment. Stakeholders should monitor payer acceptance and patient affordability, which will be critical in determining Gloperba®'s market penetration and long-term success.

Healthcare Policy Expert

The launch of Gloperba® aligns with the American College of Rheumatology guidelines, indicating industry recognition of the need for more individualized treatment options in gout management. This suggests a positive reception within the medical community, which could facilitate adoption and insurance coverage. However, the broader implications for healthcare policy, particularly regarding cost and accessibility, warrant attention. As the U.S. healthcare system grapples with rising drug prices, the reception of Gloperba®'s pricing strategy by insurers, policymakers and patient advocacy groups will be indicative of the evolving landscape in drug pricing and reimbursement.

Medical Research Analyst

The clinical advantage of Gloperba® lies in its ability to offer flexible dosing, which is crucial for gout patients with comorbidities that necessitate lower doses of colchicine. The side effect profile, with over 17% of patients on colchicine experiencing severe gastrointestinal side effects, highlights the need for alternatives like Gloperba®. While the therapeutic efficacy and safety of Gloperba® are promising, long-term clinical data and real-world evidence post-launch will be pivotal in evaluating its impact on patient outcomes and its potential to become a standard of care for gout prophylaxis.

• 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 could be 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
• Scilex plans to launch Gloperba® in the first half of 2024 with a launch price of $595 per 150ml bottle of liquid colchicine formulation.
• Scilex believes it is well-positioned to market and distribute Gloperba® in the U.S.:
  • Scilex has a direct distribution network to national and regional wholesalers and pharmacies throughout the U.S.
  • Scilex has an experienced commercial and managed care team that has successfully launched and grown market access for ZTlido® (lidocaine topical system) to more than 225 million covered lives in the U.S. as well as successfully launching Elyxyb® (celecoxib oral solution) in the U.S. in April 2023, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.

PALO ALTO, Calif., March 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 expected plans to launch Gloperba, its novel liquid colchicine formulation, in the first half of 2024 with a launch price of $595 per 150ml bottle. Gloperba is the only FDA approved liquid formulation of colchicine for the prophylaxis of acute gout flares. Over 70% of gout patients have chronic kidney disease and many suffer from gastrointestinal sensitivity, necessitating a lower dose of colchicine than the standard 0.6 mg tablet or capsule. Gloperba is expected to be the first liquid colchicine formulation that allows healthcare providers to prescribe precision dosing in at-risk patient populations, and thereby help mitigate against severe toxicity in patients. Healthcare providers can now safely and effectively manage such patients at doses below 0.6 mg once or twice daily, which is the standard dose for prophylaxis. In patients who are treated at lower doses than 0.6 mg, the 150 ml bottle of Gloperba is expected to last more than 30 days, delivering additional value to patients.

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

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

Facebook: https://www.facebook.com/scilex.pharm

LinkedIn: https://www.linkedin.com/company/scilex-holding-company

Email: info@scilexholding.com              

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^TM” 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 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 lower doses than 0.6 mg, Scilex’s plans to launch Gloperba in the first half of 2024 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%20population1)   

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 Antiinflammatory 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 launch price of Gloperba?

The launch price of Gloperba is $595 per 150ml bottle.

When does Scilex plan to launch Gloperba?

Scilex plans to launch Gloperba in the first half of 2024.

What is the indication for Gloperba?

Gloperba is indicated for the prophylaxis of painful gout flares in adults.

What is the target population for Gloperba?

Patients with comorbid conditions who may require dose adjustments are a potential target population for Gloperba.

What is the unique selling point of Gloperba?

Gloperba offers precision dosing for at-risk patient populations, potentially reducing severe toxicity risks.