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 study reached statistical significance in several important secondary endpoints, such as responder rate and remission. However, it did not reach its primary endpoint --to determine whether armodafinil treatment (150mg per day) is more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics.
This study was the third of three, Phase III studies, all of which demonstrated improvements in patient response. However, based on an evaluation of the totality of results, Teva will not proceed with regulatory filings for armodafinil for the treatment of major depression associated with bipolar I disorder. There is no material impact to the Company.
“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 Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “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.”
Armodafinil is currently available in the United States as NUVIGIL
, a prescription medicine indicated 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.
IMPORTANT SAFETY INFORMATION
(armodafinil) label includes a warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL
is not approved for use in pediatric patients for any indication.
In controlled trials in adults administered NUVIGIL
, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. Caution should be exercised when NUVIGIL
is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL
if psychiatric symptoms develop.
The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL
is available at
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.