Nuvigil armodafinil: Phase III data

Teva said it will not proceed with regulatory applications for Nuvigil to treat adults with major depression associated with bipolar I disorder after top-line data from the double-blind, international Phase III Study 3073 in 399 patients showed that once-daily 150 mg Nuvigil as adjunctive therapy to mood stabilizers and/or atypical antipsychotics missed the primary endpoint of improving IDS-C30 score from baseline up to week 8 vs. placebo as adjunctive therapy. Teva said that Nuvigil demonstrated a numerical improvement on the endpoint vs. placebo, but declined to disclose details. Teva also said that Nuvigil met several secondary endpoints vs. placebo, including responder rate and remission. ...