Teva to drop development of Nuvigil in bipolar 1 disorder

Israel-based leading generics company Teva Pharmaceutical Industries (NYSE: TEVA) has released disappointing top-line results of its final Phase III clinical study for armodafinil, the active ingredient of US biotech firm Cephalon’s Nuvigil, as adjunct therapy in adults with major depression associated with bipolar I disorder.

Teva acquired Cephalon more than two years ago for $6.8 billion, having outbid Canadian firm’s Valeant’s $5.7 billion offer for the company (The Pharma Letter March 30, 2011).

The study reached statistical significance in several important secondary endpoints, such as responder rate and remission. However, it did not reach its primary endpoint - to determine whether armodafinil treatment (150mg per day) is more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics.