Teva Pharmaceutical Industries Ltd. today 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.
“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 Michael Hayden, M.D., president of Global R&D and Chief Scientific Officer. “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.”
Bipolar disorder is 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
Armodafinil is currently available 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 1 disorder.
IMPORTANT SAFETY INFORMATION
The NUVIGIL (armodafinil) label includes a
bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL).
NUVIGIL is not approved for use in pediatric patients for any indication.
In controlled trials in adults administered NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop.