Deerfield, Ill., and La Jolla, Calif., September 11, 2014 – Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. (Nasdaq: OREX) jointly announced today that the U.S. Food and Drug Administration (FDA) has approved Contrave® (naltrexone HCI and bupropion HCI) extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.
NBSR = naltrexone SR/bupropion SR combination.
The dose of naltrexone SR is noted in the table (16 and 32 mg). The dose of bupropion SR is fixed at 360 mg/day.
*For all comparisons, P
< 0.0001 compared with placebo.
†For all comparisons, P