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AVANIR Pharmaceuticals Presents Zenvia Phase III Data in Diabetic,Peripheral Neuropathic Pain at International Congress on,Neuropathic Pain

n Rating Scale scores over the same time period as reported in the primary efficacy analysis.

-- Categorical analysis of the Pain Relief Rating Scale scores averaged at three months showed that almost twice as many patients in each of the Zenvia treatment groups obtained "a lot" of or "complete" pain relief as that in the placebo group.

-- Active treatment with both Zenvia doses significantly reduced pain interference with daily activities compared with placebo (p less than 0.0001).

-- Active treatment with both Zenvia doses significantly reduced pain interference with sleep compared with placebo (p less than 0.0001).

-- The consistency for reduced pain interference with both daily activities and reduced sleep interference across time periods during the study suggests that the benefits of Zenvia relative to placebo were maintained over the entire study period.

-- The magnitude of the improvements in quality-of-life with Zenvia was approximately 50% greater than that obtained with placebo (p=0.05 for DM/Q 45 and p=0.08 for DM/Q 30).

Cardiovascular findings were assessed by EKGs at screening, as well as clinical visits at day 1, 15 and 92. At day 15 the mean change in QTc interval compared to the screening visit was 1 millisecond in both treatment groups, versus a mean change in QTc interval of -2 milliseconds for placebo. At day 92 the mean change in QTc intervals was 5 and 2 milliseconds in the DM/Q 45 and DM/Q 30 treatment groups, respectively compared to the screening visit, versus a mean change in QTc interval of -2 milliseconds for placebo. These increases were consistent with what has been observed in previous studies. There were no cases of Torsade de Pointes or sudden death reported. The most commonly reported adverse events from this Phase III study were dizziness, nausea, diarrhea, fatigue and somnolence which were mild to moderate in nature. A higher number of patients in the DM/Q 45 and DM/Q 30 treatment groups (2
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