Teva Pharmaceutical Industries Limited (TEVA: Quote), Wednesday said that the second, Phase III study of armodafinil as adjunct therapy in adults with major depression associated with bipolar 1 disorder, did not reach statistical significance in meeting its primary endpoint.
The primary end-point for the study, which is the second of three Phase III studies was 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.
Commenting on the results, “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.” said Michael Hayden, M.D., president of Global R&D and Chief Scientific Officer.
Click here to receive FREE breaking news email alerts for Teva Pharmaceutical Industries Limited and others in your portfolio
by RTT Staff Writer
For comments and feedback: editorial@rttnews.comBusiness News