Scilex announces dosing guide for gout medication GLOPERBA

PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $37.8 million market cap firm specializing in non-opioid pain management, has announced the publication of a study that offers new dosing guidelines for GLOPERBA®, an oral liquid gout medication. The company, which maintains a healthy 72% gross profit margin and has achieved nearly 8% revenue growth over the last twelve months according to InvestingPro, continues to advance its pharmaceutical portfolio. The study, which has been peer-reviewed, provides critical data for the precise dosing of colchicine, particularly for patients with severe renal impairment—a common comorbidity in over 70% of gout sufferers.

GLOPERBA® is noted for being the first and only liquid formulation of colchicine approved for the prevention of gout flares. The recent analysis suggests that the standard solid dosage forms of colchicine may not maintain therapeutic levels in patients with renal impairment, increasing the risk of toxicity. In contrast, the study indicates that GLOPERBA®’s liquid solution enables more accurate dosing, with 0.48 mg for moderate renal impairment and 0.3 mg for severe cases, enhancing patient safety by maintaining optimal therapeutic levels.

Dr. Michael H. Pillinger, Professor of Medicine and Biochemistry and Molecular Pharmacology at NYU, emphasized the significance of these findings, stating, "This important publication will provide much needed data to guide clinical dosing of colchicine in patients with gout and chronic renal failure."

The implications of this study are particularly relevant for healthcare providers who manage the treatment of gout in patients with renal challenges. Current guidelines call for caution in dosing colchicine due to the risk of drug-drug interactions and pre-existing renal conditions, leaving dose adjustments to the clinician’s discretion. The new data from Scilex offers a more definitive framework for dosing decisions. The company’s stock has shown remarkable momentum recently, posting a 23% gain in the past week, though investors should note that InvestingPro analysis indicates the company is not yet profitable.

GLOPERBA® is manufactured in the United States and is part of Scilex’s portfolio, which includes several commercial products and product candidates aimed at treating acute and chronic pain without the use of opioids.

This announcement is based on a press release statement and provides a glimpse into the ongoing efforts to improve patient outcomes in pain management, particularly for those suffering from gout with accompanying renal impairment. While analysts anticipate sales growth for Scilex in the current year, InvestingPro subscribers have access to 8 additional key insights about the company’s financial health and growth prospects, along with detailed valuation metrics and peer comparisons that can help inform investment decisions.

In other recent news, Scilex Holding Company has reported several significant developments. The company announced its financial restructuring with a 1-for-35 reverse stock split, effective April 15, 2025, aimed at meeting Nasdaq’s minimum bid price requirements. Following this, Scilex adjusted its non-employee director compensation to align with the stock split, reducing initial and annual stock option grants significantly. Additionally, Scilex has revised its merger agreement with Denali Capital Acquisition Corp., extending the deadline for their business combination to September 30, 2025, with a potential extension to December 11, 2025, due to changes in Denali’s securities listing.

In regulatory news, the FDA granted Orphan Drug Designation to Scilex’s colchicine product, Gloperba, for treating pericarditis, recognizing its potential to address rare medical needs. Moreover, Health Canada approved ELYXYB, Scilex’s migraine treatment, marking a notable advancement for migraine sufferers in Canada. These approvals highlight Scilex’s ongoing efforts in non-opioid pain management. The company also maintains a robust portfolio, including products like ZTlido and several developmental candidates. These recent updates reflect Scilex’s strategic initiatives in corporate governance, mergers, and product development.

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