Date: 2013-08-30
Type of information:
phase: 3
Announcement: results
Company: Teva Pharmaceutical Industries (Israel)
Product: Nuvigil® (armodafinil)
Action mechanism:
Disease: major depression associated with bipolar 1 disorder
Therapeutic area: Mental diseases - CNS diseases
Country:
Trial details:
Latest
news: * On August 30, 2013, Teva Pharmaceutical Industries has 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.
Armodafinil is currently available in the United States as Nuvigil®, a prescription medicine indicated to improve wakefulness in adults who experience excessive sleepiness (ES) due to obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. Nuvigil® is not approved for use in treating major depression associated with bipolar I disorder.
* On January 23, 2013, Teva Pharmaceutical Industries has announced top-line results of its Phase III clinical program for armodafinil (Nuvigil®) as adjunct therapy in adults with major depression associated with bipolar 1 disorder. While study 3072 demonstrated a numerical improvement, 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 placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics. This is the second of three, Phase III studies; results of the first pivotal study 3071 announced in May, 2012 were positive (P=0.0097). Study 3073 and open-label extension study 3074 are ongoing; results are expected for study 3073 later this year.
