The drug met the primary endpoint and both Zenvia treatment groups had lower pain ratings than placebo patients.
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.
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.
“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, senior vice president 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 one in diabetic neuropathic pain.