Orexigen Therapeutics reports that its obesity drug Contrave has sailed through two late-stage trials and surpassed US Food and Drug Administration (FDA) effectiveness requirements.
It says that the drug not only reduces risk factors including waist circumference, midsection fat and triglycerides, but also improved levels of “good” HDL cholesterol.
It has exceeded FDA guidelines which say that at least a third of patients must lose at least 5% of their body weight, rising to twice as many compared with those who take a placebo.
The Contrave trials show that average weight loss was 8.1% and 8.2%. In a diabetes trial, 44.5% lost at least 5% of their weight after 56 weeks, compared with 18.9% of those who took a placebo. Blood-sugar levels fell by 0.6%, compared with 0.1% for the placebo group.
In the two non-diabetes trials, 48% and 56.3% reported weight loss of at least 5% after 56 weeks compared with 16.4% and 17.1% for placebo patients.
The San Diego-based company says the drug also reduces food cravings, and that it plans to seek FDA approval for Contrave early next year.
Copyright Press Association 2009