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Teva Pharmaceutical Industries Ltd Announces Top-Line Results from Second Phase III Study of Armodafinil in Patients with Depression Associated with Bipolar 1 Disorder

Wednesday, 23 Jan 2013 09:45am EST 

Teva Pharmaceutical Industries Ltd announced top-line results of its Phase III clinical program for armodafinil (NUVIGIL) 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. 

Company Quote

-190.0 -0.84%
25 Dec 2014