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news.Avanir Pharmaceuticals has presented phase III data suggesting that its diabetic peripheral neuropathic drug Zenvia significantly reduced pain compared to placebo.
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Diabetic peripheral neuropathic (DPN) pain is a common complication of diabetes that has significant impact on outcomes of concern to patients including sleep, activity and quality of life. In a multi-center, three-month, double-blind phase III trial, active treatment with Zenvia 45/30mg dosed twice daily (DM/Q 45) and 30/30mg DM/Q dosed twice daily (DM/Q 30) over a three month period, was compared to placebo.
DM/Q 45 achieved 53%, 59% and 59% improvement versus baseline, DM/Q 30 achieved 43%, 48% and 48% improvement and placebo achieved 27%, 34% and 39% improvement at days 30, 60 and 90, respectively in the Pain Rating Scale.
Active treatment with both Zenvia doses significantly reduced pain interference with daily activities and sleep compared with placebo. There were no cases of Torsade de Pointes (a life-threatening condition) or sudden death reported.
“Based on the data from this study, we conclude that Zenvia provides significantly greater improvements compared with placebo in pain-related outcomes in patients with DPN pain, including pain relief, activity and sleep. These are important outcomes to patients suffering from daily pain as a complication of their diabetes,” stated Randall Kaye, chief medical officer of Avanir Pharmaceuticals.