Results from Final Phase III Study of in Patients with Major Depression Associated with Bipolar I Disorder failed to show that it was more effective than a placebo.
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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced top-line results of its final Phase III clinical study for armodafinil (NUVIGIL) as adjunct therapy in adults with major depression associated with bipolar I disorder.
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, ” said Teva CSO and president Global R&D Dr. Michael Hayden. “We will continue to focus on our current Nuvigil indications”.
The US Food and Drug Administration (FDA) approved Nuvigil a prescription medicine to improve wakefulness in adults who experience excessive sleepiness (ES) due to obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. NUVIGIL is not approved for use in treating major depression associated with bipolar I disorder.