(By Balaseshan) Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) said its second study for armodafinil (Nuvigil) failed to demonstrate efficacy in meeting primary and secondary endpoints as adjunct therapy in adults with major depression associated with bipolar 1 disorder.
While study 3072 of Phase 3 clinical program demonstrated a numerical improvement, armodafinil treatment, at a dosage of 150 mg per day, failed to be more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics, Teva said.
This is the second of three, Phase 3 studies; results of the first pivotal study 3071 announced in May, 2012 were positive. Study 3073 and open-label extension study 3074 are ongoing; results are expected for study 3073 later this year.
In controlled trials in adults administered Nuvigil, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. The most common adverse events in controlled clinical trials (5% or greater) were headache, nausea, dizziness, and insomnia.
"We believe that armodafinil may have a unique mechanism of action in patients with depression associated with bipolar 1 disorder, and we will continue to study it as adjunct therapy in adults with this debilitating disease," said Michael Hayden, president of Global R&D and Chief Scientific Officer.
Armodafinil is currently sold under the brand name Nuvigil, which is a prescription medicine indicated to improve wakefulness in adults who experience excessive sleepiness (ES) due to obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.
Bipolar 1 disorder is defined by manic or mixed episodes that last at least a week in which an individual feels abnormally euphoric, optimistic, and energetic, and can be so severe as to require hospitalization, followed by depressive episodes typically lasting at least two weeks.
TEVA is trading up 0.03% at $37.92 on Wednesday. The stock has been trading between $36.63 and $46.65 for the past 52 weeks.