Scilex Holding Company amends its license agreement with Romeg Therapeutics, LLC, for worldwide rights to commercialize Gloperba ® , an FDA-approved prophylactic treatment for painful gout attacks and
- Gloperba ® is the first and only liquid oral version of the anti-gout drug colchicine indicated for the prophylaxis of painful gout attacks in adults.
- Over 70% of patients with gout have comorbidities that may require dose adjustment, and such patients could be a potential target population for Gloperba ®1
- More than 17% of gout patients on colchicine experienced serious gastrointestinal side effects such as diarrhea. These patients may benefit from the flexible dosing offered by Gloperba ®2
- Unlike other forms of colchicine, GLOPERBA ® liquid oral solution enables precise dosing and reduction of the daily dose in patients with severe renal impairment (0.3 mg/day).
- The incidence of gout attacks worldwide is estimated to be about 0.1 to 0.3% of the population, with a significantly higher prevalence in men compared to women, and an upward trend due to factors such as increasing rates of obesity and an aging population; however, exact figures may vary depending on the study and region analyzed.3
- The global population of people with gout has increased in the last 30 years from 22 million (95% CI 17.52-27.37) to 53 million (95% CI 43.38-66.34).4
PALO ALTO, Calif., Jan. 16, 2025 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX , Scilex or the Company), an innovative revenue generation company focused on the acquisition, development and commercialization of non-opioid pain relief products for the treatment of acute and chronic pain and, after the establishment of a proposed joint venture with the company IPMC, in neurodegenerative and cardiometabolic diseases, announced today that it entered into an amendment (Amendment) to its existing license agreement with Romeg Therapeutics, LLC (Romeg), entered into in June 2022, for former US rights to Gloperb ®. Romeg previously granted Scilex an exclusive license to commercialize Gloperba ® only in the US
Gloperba ® it is taken orally as a cough syrup. A dose of 0.6 mg per 5 ml (teaspoon) can fill that important gap in treatment where patients may have difficulty swallowing tablets. It may also provide more adaptive dosing, titration, and dose reduction options in certain populations, particularly for gout patients with renal or hepatic impairment, and reduce side effects to improve patient convenience and disease management.
According to Nature Reviews Rheumatology, gout is a common chronic crystal deposition disorder that affects between <1% and 6.8% of the population, depending on the population studied. Both the prevalence and incidence of gout appear to be increasing worldwide. Treatment of gout remains poor, with less than half of patients receiving definitive "curative" urate-lowering therapy. Adherence to urate-lowering therapy is often poor and non-adherence rates are high. Obesity and comorbidities are important risk factors for gout and are important drivers of its increasing prevalence and incidence (https://www.nature.com/articles/s41584-020-0441-1).
For more information about Scilex Holding Company, see www.scilexholding.com.
For more information about Semnur Pharmaceuticals, Inc., see www.semnurpharma.com.
For more information on Scilex Holding Company’s Sustainability Report, see www.scilexholding.com/investors/sustainability.
For more information about ZTlido ® including complete prescribing information, see www.ztlido.com.
For more information about ELYXYB ® , including complete prescribing information, see www.elyxyb.com.
For more information about Gloperba ® , including all prescribing information, see www.gloperba.com.
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About Scilex Holding Company
Scilex Holding Company is an innovative revenue generation company focused on the acquisition, development and commercialization of non-opioid products for the treatment of acute and chronic pain and, following the establishment of a proposed joint venture with IPMC, neurodegenerative and cardiometabolic diseases. Scilex targets indications with high unmet need and large market opportunity 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 product approved by the US Food and Drug Administration (FDA) for the relief of neuropathic pain associated with postherpetic neuralgia, a form of pain in nerves after herpes; (ii) ELYXYB ® , a potential first-line drug and the only ready-to-use oral solution approved by the FDA for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba ® , the first and only liquid oral version of the gout drug colchicine indicated for the prophylaxis of painful gout attacks 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 epidural corticosteroid for the treatment of lumbosacral radicular pain or sciatica, for which Scilex completed a Phase 3 study and was granted Fast Track status by the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (SP-103), a next-generation triple potency formulation of ZTlida, for the treatment of acute pain and for which Scilex recently completed a Phase 2 trial in acute pain in lower back. SP-103 has received Fast Track status from the FDA for 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 the tests were completed in the second quarter of 2022.
Scilex Holding Company is headquartered in Palo Alto, California.
About Semnur Pharmaceuticals, Inc.
Semnur Pharmaceuticals, Inc. (Semnur) is a late-stage clinical 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 epidural gel formulation in development for patients with moderate to severe chronic radicular pain/sciatica.
Semnur Pharmaceuticals, Inc. is based in Palo Alto, California
About ROMEG Therapeutics, LLC
ROMEG Therapeutics, LLC is a privately held, revenue-generating specialty pharmaceutical company headquartered in Woburn, Massachusetts. The company’s mission is to develop new FDA-approved therapies by formulating new dosage forms, improving the design and function of existing approved drugs, and expanding the clinical indications for the use of those drugs, thereby adding value to earlier scientific discoveries. The company’s first FDA-approved drug, Gloperba ® (colchicine oral solution), was launched by commercial partner Scilex in the US in 2024. The company has two active programs targeting Sjogren’s syndrome and continues to focus on developing a broad portfolio of intellectual property to offer new therapies to would provide patients and doctors with better treatment options. For more information, visit www.romegrx.com.
Forward-looking statements
This press release and any statements made at and during any presentation or meeting relating to the matters discussed in this press release contain forward-looking statements with respect 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 anticipated. Forward-looking statements include statements regarding Gloperba as the first and only liquid oral version of the gout drug, Scilex’s plans to commercialize Gloperba and the potential for an amended license agreement to accelerate Scilex’s commercialization plans, Scilex’s proposed joint venture with IPMC and potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic diseases.
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 commercialize GLOPERBA outside the U.S. Scilex’s ability to achieve joint investment or any other transaction with IPMC and the development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic diseases; 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 associated with COVID-19 (and other similar disorders); the risk that potential product candidates developed by Scilex may not progress through clinical development or obtain necessary regulatory approvals within expected timeframes or at all; risks associated with uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will not be able to successfully market or gain market acceptance of its product candidates; the risk that Scilex product candidates will not be beneficial to patients or will not be successfully commercialized; the risk that Scilex overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe those therapies; the risk that the results of trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive results; risks that previous results from clinical and investigational 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 o 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, unless may be required by law.
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References
- Comorbidities of gout and hyperuricemia in the US general population: NHANES 2007-2008.
- Stewart et al. Arthritis Research and Therapy (2020) 22:28; https://doi.org/10.1186/s13075-020-2120-7
- https://www.sciencedirect.com/science/article/pii/S0049017220301220
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10285625/
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly owned subsidiary of Scilex Holding Company. FDA review of the trademarked name 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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Source: Scilex Holding Company
