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news.Avanir Pharmaceuticals has said that a phase II clinical trial evaluating escalating doses of Neurodex in the treatment of painful diabetic neuropathy indicates that the investigational drug was well tolerated up to the highest target dose.
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The trial assessed the safety and tolerability of Neurodex, a proprietary formulation of dextromethorphan and low dose quinidine. Patient assessments also demonstrated statistically significant improvements in sleep, present pain intensity, activity and pain rating scales.
Adverse events related to Neurodex were mild to moderate and were consistent with the previously known effects of the drug.
“We are looking forward to the results from our ongoing phase III study in mid-2007,” noted Randall Kaye, vice president of Medical Affairs of Avanir.
Assuming positive outcomes, Avanir expects the current study will be the first of two phase III clinical trials that will likely be needed before submitting a new drug application for this indication.
Painful diabetic neuropathy may affect more than 50% of patients with diabetes as their disease progresses, according to the American Diabetes Association.