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Teva Issues Results from Final Phase III STudy of Armodafinil for Depression, Says Trial Didn't Meet Primary Endpoint, Sees No Material Effect

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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced top-line results of its final Phase III clinical study for armodafinil (NUVIGIL^®) as adjunct therapy in adults with major depression associated with bipolar I disorder. The study reached statistical significance in several important secondary endpoints, such as responder rate and remission. However, it did not reach its primary endpoint --to determine whether armodafinil treatment (150mg per day) is more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics.

This study was the third of three, Phase III studies, all of which demonstrated improvements in patient response. However, based on an evaluation of the totality of results, Teva will not proceed with regulatory filings for armodafinil for the treatment of major depression associated with bipolar I disorder. There is no material impact to the Company.

Posted-In: News FDA


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