Orexigen Obesity Drug Meets Goals in 3 Studies
FDA approval for the obesity drug Orexigen could come next year.
July 20, 2009— -- SAN DIEGO (AP) -- Orexigen Therapeutics Inc. said Monday that its obesity-drug candidate Contrave met its main goals in three late-stage clinical trials, and also surpassed a Food and Drug Administration requirement for effectiveness.
Patients who took Contrave had significantly greater weight loss than those who took a placebo, and the drug also reduced other risk factors like waist circumference, the company said. For diabetes patients, the drug also reduced blood sugar levels.
The San Diego-based company said it plans to seek FDA approval for Contrave in early 2010.
Orexigen said the drug also reduced food cravings and allowed patients to take better control of their eating. Its shares jumped $1.52, or 28 percent, to $6.97 in premarket trading on Monday. The stock closed Friday at $5.69.
In the two non-diabetes trials, Orexigen said that after 56 weeks, 48 percent of patients and 56.3 percent reported weight loss of at least 5 percent. That compared to 16.4 percent and 17.1 percent for the placebo patients. That more than met FDA testing guidelines that require at least a third of patients must lose at least five percent of their body weight. At least twice as many patients must reach the 5 percent goal compared with those who take a placebo.
In those trials, the Contrave patients had mean weight loss of 8.1 percent and 8.2 percent, or 17.6 pounds and 17.5 pounds. In the diabetes trial, 44.5 percent of patients lost at least 5 percent of their weight after 56 weeks, compared to 18.9 percent of patients who took a placebo. Contrave patients reduced their blood sugar by 0.6 percent, compared to 0.1 percent for the placebo group.
The non-diabetes involved 1,742 patients and 1,496 patients, respectively, while 505 people with type 2 diabetes participated in the third trial.
Orexigen said the drug reduced risk factors including waist circumference, midsection fat and triglycerides, and improved levels of "good" HDL cholesterol.
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