Teva reported Wednesday that a Phase III trial of Nuvigil (armodafinil) as adjunct therapy in adults with major depression associated with bipolar 1 disorder failed to demonstrate efficacy in meeting both primary and secondary endpoints. Although Study 3072 showed a numerical improvement, the company noted that it did not reach statistical significance in meeting its main goal of determining whether Nuvigil is more effective than placebo as adjunct therapy to mood stabilisers or atypical antipsychotics.
Teva indicated that an earlier late-stage trial of the drug was positive with results from a third study expected later this year. “While we are disappointed that the second study did not reach statistical significance, we are firmly committed to continuing with the third, Phase III trial based on the promising results of the first study, the trend seen in the second, and comparable safety results between the two studies," remarked Teva president of global R&D Michael Hayden.
Nuvigil is currently approved to improve wakefulness in individuals with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder or narcolepsy. The drug was developed by Cephalon and acquired by Teva when it purchased Cephalon in 2011.
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