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Avanir Pharmaceuticals Announces Positive Results of Phase III,Study for Zenvia in Diabetic Neuropathic Pain

ry endpoint of Peripheral Neuropathy Quality of Life Scale Composite score, the DMQ 45 patients showed a greater improvement than placebo patients (p=0.05) and the DMQ 30 patients showed a greater improvement than placebo patients (p=0.08).

Overall, the safety data from this study are consistent with data from previous studies. The most commonly reported adverse events were dizziness, nausea, diarrhea, fatigue and somnolence and were generally mild to moderate in nature. A higher number of patients in the DMQ 45 and DMQ 30 treatment groups (25.2% and 21.0%, respectively) discontinued due to an adverse event than compared to placebo (11.4%). There were no significant differences in serious adverse events with 7.6%, 4.8% and 4.1% reported in the DMQ 45, DMQ 30 and placebo groups, respectively. In addition, no deaths occurred throughout the study. Further safety and efficacy analyses are on-going and are expected to be presented at an upcoming public medical forum.

"We are extremely encouraged by the results of this trial which are consistent with Avanir's prior Phase II study in patients with diabetic neuropathic pain," said Randall Kaye, MD, Senior Vice President and Chief Medical Officer of Avanir Pharmaceuticals. "We look forward to meeting with the FDA to discuss the next study for Zenvia for the treatment of diabetic neuropathic pain given the robustness of the clinical results."

"Current treatment options are either partially effective or don't work at all for more than one-half of people suffering from diabetic neuropathic pain. The results of this study provide additional evidence that Zenvia, if approved, may be a safe and effective treatment option for the millions of Americans suffering from diabetic neuropathic pain," said Keith A. Katkin, President and CEO of Avanir Pharmaceuticals. "Avanir now has two Phase III Zenvia programs in areas with significant unmet medical need, one in Involuntary Emotional Expression Disorder (IEED) and on
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