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Investigation of the impact of urine handling procedures on interpretation of urinalysis findings and product safety in subjects treated with ezogabine

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Author(s): Brickel N | DeRossett S | Buraglio M | Evans C | Jones S

Journal: Therapeutics and Clinical Risk Management
ISSN 1176-6336

Volume: 2013;
Issue: default;
Start page: 207;
Date: 2013;
Original page

ABSTRACT
Neil Brickel,1 Sarah DeRossett,2 Mauro Buraglio,3 Christopher Evans,4 Siôn Jones51Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, Middlesex, UK; 2Neurosciences Therapy Area Unit, GlaxoSmithKline, Research Triangle Park, NC, USA; 3Neurosciences Therapy Area Unit, GlaxoSmithKline, Stevenage, Hertfordshire, UK; 4Bioanalytical Science and Toxicokinetics, PTS-DMPK, GlaxoSmithKline, King of Prussia, PA, USA; 5Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, Middlesex, UKBackground: Ezogabine (also known by the international nonproprietary name of retigabine) is an antiepileptic drug codeveloped and comarketed by Valeant Pharmaceuticals North America and GlaxoSmithKline, which reduces neuronal excitability by enhancing the activity of potassium channels and has the potential to have effects on the urinary system through a pharmacologic action on bladder smooth muscle. In a single post-herpetic neuralgia trial, but not in an extensive epilepsy development program, proteinuria was unexpectedly reported in patients receiving ezogabine. Consequently, investigations were conducted to determine whether the reported proteinuria represented a true or false-positive finding.Methods: Patients receiving ezogabine 900–1200 mg/day in an open-label extension (Study 303) of a Phase III epilepsy trial voluntarily provided urine samples. Fresh samples were analyzed immediately at the study site, and stabilized aliquots were analyzed 1–3 days after collection at two central laboratories. In an open-label study in healthy volunteers receiving ezogabine 600–900 mg/day (Study RTG114137), urine samples were analyzed fresh (

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