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Teva halts development of Nuvigil in bipolar disorder

Shelves plan to expand use of sleep disorder therapy

Teva Nuvigil armodafinil

Teva Pharmaceutical has halted a programme investigating the use of its sleep disorder treatment Nuvigil to treat depression after disappointing late-stage trial results.

The Israel-based pharma company said that Nuvigil (armodafinil) failed to demonstrate it was significantly more effective than placebo during a phase III trial investigating its use as an adjunct therapy in adults with major depression associated with bipolar I disorder.

As a result, Teva said it “will not proceed with regulatory filings” for the drug in this indication despite good results in secondary endpoints, such as responder rate and remission.

“While this study demonstrated a numerical improvement, we are disappointed that armodafinil did not reach statistical significance,” said Dr Michael Hayden, Teva's president of global R&D and chief scientific officer.

Teva gained the rights to Nuvigil as part of its acquisition of Cephalon in 2011, and markets the drug to improve wakefulness in adults who experience excessive sleepiness due to sleep disorders, such as sleep apnea or narcolepsy.

Nuvigil made $347m for Teva during 2012 in these indications, but the company was keen to expand its use ahead of patent expiry in 2016.

Early trial results studying the drug as a depression treatment were promising, including a successful phase III study reported in May 2012, with Teva's head of global medicines John Congleton commenting at the time that the company could launch the drug for bipolar disorder as early as 2014.

However, cracks began to show at the beginning of the year when the company posted disappointing results from another phase III trial, and these concerns have now been confirmed following the latest data.

Any further plans to expand the use of the product now seem unlikely, with Dr Hayden commenting: “We will continue to focus on our current Nuvigil indications.”

Article by
Thomas Meek

3rd September 2013

From: Research

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