Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) will halt development of Nuvigil (armodafinil) for the treatment of major depression associated with bipolar I disorder, after the Phase III clinical trial failed to show that it was more effective than a placebo.
The current study was the third Phase III clinical trial, all of which Teva said demonstrated improvements in patient response. It added that on the basis of an evaluation of the totality of results, it will not proceed with regulatory filings for the drug. "There is no material impact to the company," said Teva.
“While this study demonstrated a numerical improvement, we are disappointed that armodafinil did not reach statistical significance. Teva remains committed to advancing science in serious conditions affecting the central nervous system," said Teva CSO and president Global R&D Dr. Michael Hayden. “We will continue to focus on our current Nuvigil indications and we remain committed to improving wakefulness in adult patients with excessive sleepiness associated with shift work disorder, obstructive sleep apnea or narcolepsy."
The US Food and Drug Administration (FDA) approves Nuvigil for improving wakefulness in adults who experience excessive sleepiness, due to obstructive sleep apnea, shift work disorder, or narcolepsy. It is not approved to treat major depression associated with bipolar I disorder.
Published by Globes [online], Israel business news - www.globes-online.com - on September 1, 2013
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