Scilex Holding Company Announces Results from Market Research with Rheumatologists Reveal a High Degree of Interest in Gloperba® as a Liquid Colchicine Formulation Designed for Precision Dosing
- Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine, catering to a significant market opportunity in the projected $2.0 billion U.S. gout treatment market by 2028.
- Scilex Holding Company has an experienced commercial and managed care team, positioning them well for the marketing and distribution of Gloperba®.
- The market research study among rheumatologists indicates a high level of interest in Gloperba® as a precision dosing option for at-risk gout patients, reflecting a positive reception from healthcare professionals.
- None.
Insights
The introduction of Gloperba®, as a liquid oral colchicine, represents a significant advancement in the treatment of gout, addressing a specific unmet need within a growing patient population. The projected market growth to $2.0 billion by 2028 underscores the potential financial implications for Scilex and its stakeholders. The emphasis on Gloperba® catering to over 70% of gout patients with comorbid conditions requiring dose adjustments signifies a strategic targeting of a substantial subset of the market.
The commercial strategy leveraged by Scilex, utilizing its established distribution network and managed care team, mirrors successful approaches taken with previous products such as ZTlido® and Elyxyb®. This indicates a robust infrastructure capable of supporting Gloperba®'s market penetration. The market research among rheumatologists suggesting a high degree of interest further validates the product's market viability and potential adoption rate.
However, ongoing discussions with the FDA regarding dosing recommendations are critical to monitor as they could impact the product's labeling and usage, which in turn may affect market adoption and sales projections. It is essential for investors to consider both the commercial potential and regulatory developments when evaluating Scilex's business prospects.
Analyzing the financial landscape, Scilex's positioning in the non-opioid pain management market with the introduction of Gloperba® taps into a significant revenue stream within the pharmaceutical industry. Given the high prevalence of gout and the increase in cases, a novel formulation such as a liquid oral solution can command a premium, especially when addressing gastrointestinal side effects—a known issue with over 17% of gout patients. Flexible dosing could also translate into a competitive advantage, potentially increasing market share.
Investors should note the importance of the company's past success with other products as an indicator of its potential to navigate the market effectively. The company's experience and established distribution capabilities are likely to facilitate a successful launch and sustained growth. Nonetheless, it is crucial to await the final FDA approval and any further clinical data that could influence the product's trajectory and, consequently, the company's financial performance.
- 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. 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 target population for Gloperba®3 - Over
17% of gout patients had gastrointestinal side effects like diarrhea. These patients may benefit from flexible dosing offered by Gloperba®4 - Scilex is well-positioned to market and distribute Gloperba®:
- 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., Dec. 19, 2023 (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 that 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 is currently in discussions with the U.S. Food and Drug Administration (FDA) regarding the dosing recommendations for these patient populations.
For more information on Gloperba®, visit https://www.gloperba.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 is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and reached agreement on a path forward to file an NDA for SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain (Sciatica) with the FDA. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product ZTlido® in October 2018, in-licensed a commercial product Gloperba® in June 2022, and launched its third FDA-approved product Elyxyb® in April 2023. It is also developing its late-stage pipeline, which includes a pivotal Phase 3 candidate, and one Phase 2 and one Phase 1 candidate. Its commercial product, ZTlido® (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 Gloperba’s potential to further expand Scilex’s non-opioid portfolio and its potential to address high unmet needs in treating gout, the potential market size and the size of the patient population for gout in the U.S., the findings of the recent market research study with rheumatologists, Scilex’s plans to initiate a Phase 2/3 trial in chronic neck pain in 2024 and plans to initiate Phase 2 trials in 2024 for SP-104, Scilex’s belief that it is well positioned to continue its growth over the next several years, Scilex’s long-term objectives and commercialization plans, Scilex’s potential to attract new capital, future opportunities for Scilex, Scilex’s future business strategies, the expected cash resources of Scilex and the expected uses thereof; Scilex’s current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity; statements regarding ZTlido®, Gloperba®, ELYXYB®, SP-102 (SEMDEXA™), SP-103 or SP-104, if approved by the FDA; Scilex’s development and commercialization plans; and Scilex’s products, technologies and prospects.
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 for SP-102, SP-103 or SP-104 may not be successful; risks that the prior results of the clinical 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 set forth in Scilex’s filings with the Securities and Exchange Commission. 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,%
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 the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.
All other trademarks are the property of their respective owners.
© 2023 Scilex Holding Company All Rights Reserved.
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