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

s (p less than 0.0001 for both comparisons), demonstrating significantly greater reductions in pain compared with placebo. Pain score averaged over the study periods were significantly lower than placebo in the DM/Q 45 arm for comparisons at days 30, 60 and 90 (p less than 0.0001 for each comparison) and in the DM/Q 30 arm (p less than 0.0001 at days 30 and 60, p=0.0071 at day 90). The consistency in the magnitude of response suggests that the pain reduction obtained with active treatment relative to placebo were maintained over the entire study duration.

-- Improvements from baseline with active treatment appeared to be dose dependent, with the higher dose resulting in improvements that were almost twice as great as placebo.

-- Both doses demonstrated significantly better improvements in pain from baseline that were maintained over the duration of the study.

-- The incidence of AEs was higher in the DM/Q 45 group (91%), compared with placebo (80%) and DM/Q 30 (79%), with the proportion of patients discontinuing due to an AE higher in both active treatments compared with placebo.

-- The most common AEs were dizziness, nausea, diarrhea, fatigue and somnolence and were generally mild to moderate in severity.

-- There were no statistically significant differences in serious adverse event rates reported in the DM/Q 45, DM/Q 30 and placebo groups, and no deaths occurred during the study.

Poster: "IMPROVED PATIENT-CENTERED OUTCOMES WITH DEXTROMETHORPHAN/ QUINIDINE VS PLACEBO IN A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL INVESTIGATING PAINFUL DIABETIC PERIPHERAL NEUROPATHY," reports on the secondary efficacy endpoints in the Phase III study on outcomes of importance to patients, including pain relief, sleep and quality-of-life. Highlights include:

-- Both Zenvia doses were significantly superior to placebo in relieving pain. The pattern reported in the Pain Relief Scale complemented that shown by the Pai
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