J. Kevin Buchi, Chief Operating Officer, commented on the Nuvigil for bipolar depression phase III program. He stated, "The label expansion program for Nuvigil in bipolar depression is advancing according to plan. Two of the three phase III studies are on track to be completed by the end of this year. The third is scheduled for completion in the second quarter of 2012. If the first two studies are positive, and the subsequent submission is approved by the FDA, we will be prepared to launch in 2013."
Source: Q4 2010 earnings conference call, 2/10/11.
Frank Baldino, JR., PH.D., Chairman & CEO, maintained guidance for data from the Nuvigil in bipolar disorder. He stated, "Enrollment in our eight-week, 1,200-patient phase III bipolar depression program is underway with expected study completion by the end of 2011. The primary endpoint is a depression end point. If the results of our phase III bipolar program are consistent with the results from our phase II program, we may have the opportunity for an additional label indication by late 2012. This program represents a significant opportunity to treat millions of patients suffering from bipolar depression."
Source: Q2 2010 earnings conference call, 7/27/10.
Frank Baldino, JR., PH.D., Chairman & CEO, gave guidance for the Nuvigil in bipolar depression program. He stated, "Lastly, we are studying Nuvigil in patients with bipolar depression. We're encouraged by our 257 patient Phase IIb trial in patients suffering from this disease. Enrollment in our 1,200 patients Phase III program is underway with expected study completion in the fourth quarter of 2011. If we can show similar results in our Phase III bipolar program, we may have an additional label indication by late 2012 and the opportunity to treat millions of people suffering from bipolar depression."
Source: Q1 2010 earnings conference call, 5/04/10.
C10953/3071 - The primary objective of the study is to determine whether armodafinil treatment, at dosages of 150 and 200 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
Estimated Enrollment: 400
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01072929?term=Nuvigil+bipolar&rank...
|NUVIGIL (armodafinil) (1) ESD bipolar disorder||Psychiatry||Excessive sleep disorder (ESD) (bipolar disorder)||Wake promoting agent||Unknown|
Mechanism of action: The mechanism of action of Nuvigil, a SM, is unknown.
Phase of Development: III
Event Type: Data: Phase III trial results
Dates: 2011-11-01 - 2011-12-31