( daily activities (p less than 0.0001) ...)AVANIR Pharmaceuticals Presents Zenvia Phase III Data in Diabetic,Peripheral Neuropathic Pain at International Congress on,Neuropathic Pain,Health

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

-- QTc interval mean change 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 at day 92.

-- There were no cases of Torsade de Pointes (a life-threatening condition) or sudden death reported.

"The Phase III trial data indicate that both doses of Zenvia demonstrated significantly superior reduction of pain compared with placebo in patients with DPN pain. Additionally, Zenvia was generally safe and well tolerated, and safety data were consistent with previous clinical studies with no new safety signals noted," said study investigator Aziz Shaibani, MD, FACP, Clinical Assistant Professor, Department of Medicine, Baylor College of Medicine, Houston, Texas.

"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, MD, Chief Medical Officer of AVANIR Pharmaceuticals.

Highlights of Posters

Poster: "EFFICACY AND SAFETY OF DEXTROMETHORPHAN/QUINIDINE IN TREATING PAINFUL DIABETIC PERIPHERAL NEUROPATHY: RESULTS OF A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL," includes:

-- Treatment with Zenvia resulted in a more rapid and marked reduction in pain scores relative to placebo, with a trend toward greater pain reduction at the higher dose.

-- Both active treatment groups had lower pain ratings than placebo patient
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