Orexigen's Contrave Takes Off the Weight

Obesity patients treated with a weight-loss combination pill from Orexigen Therapeutics (OREX) lost an average of more than 13 pounds, or just more than 6% of their body weight, after one year of treatment, according to results from two phase III studies released Monday.

In a third study also released Monday, obese patients who suffered from Type 2 diabetes were able to reduce blood sugar levels but lost less weight.

Orexigen said three studies of the weight-loss drug known as Contrave, which combines two older medicines into a single pill, met their pre-specified weight loss and safety goals. The company plans to seek regulatory approval for Contrave in the first half of 2010 from the U.S. Food and Drug Administration.

Patients treated with a placebo pill for one year lost about three pounds, or just more than 1% of their body weight in the first two studies. This puts the placebo-adjusted percentage of weight lost by Contrave patients at 5% -- matching one of two efficacy standards mandated by the FDA for all experimental obesity drugs.

Overall, three times as many Contrave patients were able to shed pounds compared with patients treated with a placebo for one year.

In the first two studies, 48% and 56% of Contrave patients, respectively, lost at least 5% of their body weight. By comparison, 16% and 17% of placebo patients lost 5% body weight.

The FDA requires that any new obesity drug at least double the percentage of patients who lose 5% of their body weight compared with placebo, so Contrave easily surpassed this standard.

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