Cephalon, a biopharmaceutical company, has reported positive results from a Phase II clinical trial of Nuvigil tablets as adjunctive therapy for treating major depressive disorder in adults with bipolar I disorder.
The eight-week, double-blind, placebo-controlled study evaluated the efficacy and safety of Nuvigil (150mg/day) as an adjunctive therapy to mood stabilizers in 257 patients with bipolar I disorder, who experienced a major depressive episode that was not completely managed by their other treatments.
According to Cephalon, patients in the study taking Nuvigil as adjunctive therapy showed improvement of depressive symptoms (p=0.042) as measured on the primary endpoint – the 30-Item Inventory of Depressive Symptomatology, Clinician-Rated (IDS-C30) scale. Nuvigil was generally well-tolerated in the study. The incidence of mania, hypomania, depression and suicidal ideation were comparable between the Nuvigil and placebo groups.
Cephalon is preparing to launch Nuvigil, the longer-lasting isomer of modafinil, in the third quarter of 2009. Nuvigil is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder, and narcolepsy.
Lesley Russell, executive vice president and chief medical officer of Cephalon, said: We are encouraged that the results of this study point toward the potential utility of Nuvigil in managing the depressive episodes in bipolar I disorder. We now plan to conduct phase three trials to further evaluate the efficacy and safety of Nuvigil in this patient population.