Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar ...( Company Plans to Advance to Phase Thr...),Health

Company Plans to Advance to Phase Three Trials

FRAZER, Pa., March 17 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today 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-tolerat
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