Teva drops Nuvigil for depression

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said it will not proceed with regulatory applications for Nuvigil armodafinil to treat adults with major depression associated with bipolar I disorder. The news came after data from the Phase III Study 3073 showed once-daily Nuvigil as adjunctive therapy to mood stabilizers and/or atypical antipsychotics missed the primary endpoint of improving depression as measured by the IDS-C30 scale from baseline to up to week eight vs. placebo as adjunctive therapy. Teva had previously reported that Nuvigil as adjunctive therapy missed the same primary endpoint in the Phase III Study 3072 but met the endpoint in the Phase III Study 3071. Both of these trials also enrolled patients with major depression associated with bipolar I disorder.

Nuvigil, a single-isomer of modafinil, is approved in the U.S. to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work sleep disorder. H. Lundbeck A/S (CSE:LUN) has exclusive, Canadian rights to Nuvigil. ...