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

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Apr 18, 2007 - Avanir Pharmaceuticals (NASDAQ:AVNR) today announced positive top-line results from the company's Phase III clinical trial evaluating the investigational drug Zenvia(TM) (dextromethorphan hydrobromide/quinidine sulfate ("DMQ")), an NMDA antagonist and sigma-1 agonist, in diabetic neuropathic pain.

The primary endpoint of the trial was based on the daily diary entries for the Pain Rating Scale as defined in the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). In the trial, two doses of Zenvia, 45/30 mg DMQ dosed twice daily ("DMQ 45") and 30/30 mg DMQ dosed twice daily ("DMQ 30"), were compared to placebo based on daily patient diary entries for the Pain Rating Scale. Both Zenvia treatment groups had lower pain ratings than placebo patients (p less than 0.0001 in both cases). In the DMQ 45 patient group, average reductions were significantly greater than placebo patients at Days 30, 60, and 90 (p less than 0.0001 at each time point). In the DMQ 30 patient group, average reductions were also significantly greater than placebo patients at Days 30 and 60 (p less than 0.0001) and Day 90 (p=0.007).

Zenvia also demonstrated statistically significant improvements in a number of key secondary endpoints including the Pain Relief Ratings Scale and the Pain Intensity Ratings Scale. The secondary endpoints compared the baseline value to the average rating values at each study visit after randomization. The average pain relief reductions as measured on the Pain Relief Rating Scale were greater for the DMQ 45 patient group (p=0.0002) and for the DMQ 30 patient group (p=0.0083), compared with placebo. In addition, the DMQ 45, but not the DMQ 30, patient group demonstrated statistically significant improvements in the Pain Intensity Rating Scale compared with placebo (p=0.029). Although not powered to detect differences in the seconda
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