Teva second Phase III depression study of armodafinil fails to meet endpoints

Study 3072, second of three, Phase III studies, has not achieved statistical significance to meet primary endpoint although numerical improvement was established.

The study was designed to determine if 150mg of armodafinil administered each day is more effective as adjunct therapy for mood stabilizers and/or atypical antipsychotics compared to placebo.

Teva Global R&D president and chief scientific officer Michael Hayden said the company is committed to clinical development program with the ongoing third phase III trial, on the basis of positive results from the first trial, a trend observed in the second one, and comparable safety results between the studies.

"Bipolar 1 disorder is a complex disease where there remains a significant unmet patient need to successfully treat associated depressive episodes," Hayden added.

"We believe that armodafinil may have a unique mechanism of action in patients with depression associated with bipolar 1 disorder, and we will continue to study it as adjunct therapy in adults with this debilitating disease."

First pivotal study 3071 demonstrated positive results.