Teva Pharmaceutical Industries Ltd. 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.
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