Cephalon, Inc. has announced positive results from a phase two clinical trial of NUVIGIL(R) (armodafinil) Tablets [C-IV] as adjunctive therapy for treating major depressive disorder in adults with bipolar I disorder.
An estimated two million American adults are affected by bipolar I disorder, which is characterized by fluctuations between extreme highs (manic) and lows (depressed) in mood. People with bipolar disorders cycle between periods of manic or depressive mood and typically spend more time in the depressed phase of the illness.
The eight-week, double-blind, placebo-controlled study evaluated the efficacy and safety of NUVIGIL (150 mg/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. 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. The IDS-C30 scale is an instrument used to evaluate depressive episodes and associated symptoms. The results of this study will be presented at an upcoming medical meeting.
"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," said Dr. Lesley Russell, Executive Vice President and Chief Medical Officer at Cephalon. "We now plan to conduct phase three trials to further evaluate the efficacy and safety of NUVIGIL in this patient population."
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. There were two serious adverse events of mania in the placebo group but none in the NUVIGIL group. Other adverse events that occurred more frequently in the NUVIGIL versus the placebo group included restlessness and anxiety.
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 (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. NUVIGIL is not approved for the treatment of bipolar disorders, depression or their associated symptoms.
The U.S. Food and Drug Administration-approved prescribing information for NUVIGIL, including a bolded warning, is available at www.NUVIGIL.com .