Armodafinil (Nuvigil) Fails Phase III Trial in Patients With Bipolar Disorder

Results have been reported from the phase III clinical trial program for armodafinil (Nuvigil, Teva Pharmaceuticals) as adjunctive therapy in adults with major depression associated with bipolar 1 disorder. The study failed to reach statistical significance in meeting its primary objective — to determine whether treatment with armodafinil 150 mg daily is more effective than placebo as an adjunct to mood stabilizers and/or atypical antipsychotics.

This is the second of three phase III studies of armodafinil; results from the first pivotal trial, announced in May 2012, were positive (P = 0.0097 vs. placebo).

Nuvigil (armodafinil) is indicated to improve wakefulness in adults who experience excessive sleepiness due to obstructive sleep apnea, shift work disorder, or narcolepsy. The drug is not approved for use in treating major depression associated with bipolar 1 disorder.

Bipolar disorder is among the top 20 most severely disabling disorders. The condition is characterized by manic or mixed episodes lasting at least 1 week in which the individual feels abnormally euphoric, optimistic, and energetic, and can be so severe as to require hospitalization, followed by depressive episodes typically lasting at least 2 weeks. The depressive episodes of bipolar 1 disorder can be so severe that the person cannot function normally at work, school, or home.

Source: Teva Pharmaceuticals; January 23, 2013.