ALXA just out... Teva reports top-line results from Phase III study of NUVIGIL
Teva Pharmaceutical announced top-line results of its final Phase III clinical study for armodafinil 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 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, Teva said.
