Results from IGNITE study of Contrave (bupropion and naltrexone) published in Obesity- Orexigen Therapeutics

Orexigen Therapeutics has announced that results of its IGNITE study of Contrave (bupropion and naltrexone) in obesity were published online by Obesity journal. The IGNITE study was an open-label randomized Phase IIIb study designed to evaluate the use of Contrave in combination with a commercially-available comprehensive lifestyle intervention program compared with usual care in a real-world weight-loss setting.

Study results showed that treatment with Contrave, when used in a manner consistent with prescribing information in the U.S. and EU, resulted in a significant decrease in body weight compared with usual care. At week 16, participants receiving Contrave had to achieve at least 5 percent weight loss to continue therapy, consistent with U.S. and EU prescribing information. The primary endpoint of the study was the percent change in body weight per protocol population; secondary endpoints included the percentage of patients achieving a loss of at least 5 percent, 10 percent or 15 percent of baseline body weight.

At 26 weeks, results showed that per protocol population, study participants treated with Contrave lost significantly more weight than usual care participants (9.5 percent vs. 0.9 percent (p<0.0001)). Significantly more Contrave-treated patients achieved three weight loss thresholds than usual care-treated patients.

See: "Method-of-use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity." Amy Halseth et al. Obesity 27 December 2016 DOI: 10.1002/oby.21726