Orexigen Therapeutics, a US biopharmaceutical company focused on the treatment of central nervous system disorders, presented both consolidated weight loss results from a Phase IIb trial of Contrave, a proprietary formulation of the narcotic and alcohol dependence drug naltrexone and bupropion and key secondary endpoint data on the agent, which is one of the company's two late-stage obesity drug candidates.
The Phase IIb evaluation was a 24-week, double-blind, placebo-controlled, multicenter trial with a 24-week extension that randomized 419 healthy obese patients to either: placebo, bupropion sustained-release 400mg, naltrexone immediate-release 48mg or a combination of bupropion SR 400mg and naltrexone IR 16mg, 32mg or 48mg daily. The previously reported efficacy results at 48 weeks for weight loss from baseline across the three Contrave dosage groups ranged from 5.0% to 6.6% (last observation carried forward analysis) and from 8.0% to 10.7% (completer analysis). The company also reported that 24-week Contrave clinical responders continued to lose additional weight through 48 weeks.
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