The Phase III trial failed to meet its primary endpoint.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced failure in the preliminary results of the Phase III clinical trial of armodafinil (Nuvigil) as an adjunct therapy in adults with major depression associated with bipolar 1 disorder. Although the trial found improvement in patients, 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 a placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics.
This was the second of three Phase III studies. The results of the first pivotal study, announced in May 2012, were positive. The third study and an open-label extension study are ongoing, and results of the third study are due later this year.
"While we are disappointed that the second study did not reach statistical significance, we are firmly committed to continuing with the third, Phase III trial based on the promising results of the first study, the trend seen in the second, and comparable safety results between the two studies. Bipolar 1 disorder is a complex disease where there remains a significant unmet patient need to successfully treat associated depressive episodes,” said Teva chief scientific officer and Global R&D president Dr. Michael Hayden said. “We believe that armodafinil may have a unique mechanism of action in patients with depression associated with bipolar 1 disorder, and we will continue to study it as adjunct therapy in adults with this debilitating disease. At Teva, we are dedicated to advancing the science in serious neuropsychiatric conditions, such as this."
Teva said that bipolar disorder was 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.
Published by Globes [online], Israel business news - www.globes-online.com - on January 23, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013
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