Teva Pharmaceutical Industries Ltd. (TEVA) recently announced disappointing top-line data from the final phase III study evaluating Nuvigil (armodafinil) as adjunct therapy in adults with major depression associated with bipolar I disorder.
Although results showed that Nuvigil achieved statistical significance in several important secondary endpoints (like responder rate and remission), it failed to achieve the primary endpoint. The primary endpoint was to see whether Nuvigil (150mg per day) was more effective compared to placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics.
Nuvigil is currently approved for the improvement of wakefulness in adults who experience excessive sleepiness due to obstructive sleep apnea, shift work disorder, or narcolepsy. Nuvigil sales were $157 million in the first half of 2013. Teva was looking to drive sales by expanding the label into additional indications. However, based on the final phase III study results, Teva has decided that it will not go ahead with regulatory filings for expanding Nuvigil’s label for the treatment of major depression associated with bipolar I disorder.
Teva currently carries a Zacks Rank #3 (Hold). The company is going through a tough transition period given fewer large generic opportunities, potential new competition for branded products (especially Copaxone) and a higher cost base.
However, we are encouraged by Teva’s plans to improve its position. Teva said that it intends to accelerate growth platforms, protect and expand core franchises, expand its global presence, pursue strategic deals and reduce the cost base. We expect investor focus to remain on the execution of the company’s new strategy.
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