Teva Pharmaceutical Industries Ltd. announced top-line results of its Phase III clinical program for armodafinil (NUVIGIL(R)) as adjunct therapy in adults with major depression associated with bipolar 1 disorder. While study 3072 demonstrated a numerical improvement, it did not reach statistical significance in meeting its primary endpoint to determine whether armodafinil treatment, at a dosage of 150 mg per day, is more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics. This is the second of three, Phase III studies; results of the first pivotal study 3071 announced in May, 2012 were positive (P=0.0097).

Study 3073 and open-label extension study 3074 are ongoing; results are expected for study 3073 later this year. Bipolar disorder is among the top 20 most severely disabling disorders. Bipolar 1 disorder is defined by manic or mixed episodes that last at least a week in which an individual feels abnormally euphoric, optimistic, and energetic, and can be so severe as to require hospitalization, followed by depressive episodes typically lasting at least two weeks.

The depressive episodes of bipolar 1 disorder can be so severe that the person cannot function normally at work, school, or home.