Avanir Gets Positive Phase III Zenvia Results

Avanir Pharmaceuticals achieved positive results from its Phase III trial evaluating Zenvia, 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 FDA’s SPA. In the trial, two doses of Zenvia, 45/30 mg DMQ and 30/30 mg DMQ dosed twice daily, were compared to placebo based on patient diary entries for the Pain Rating Scale. Both Zenvia treatment groups had lower pain ratings than placebo patients. In the DMQ 45 and DMQ 30 patient groups, average reductions were significantly greater than placebo patients at Days 30, 60, and 90. 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.