Orexigen obesity drug shows added benefits-studies

Sat Oct 24, 2009 1:00pm EDT
 
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* 34.5-48.2 pct of patients lose at least 10 pct of weight

* 17.2 to 23 pct lose at least 15 pct

* Triglycerides significantly lower in high risk group

* Blood sugar significantly lower in high risk diabetics

By Bill Berkrot

NEW YORK, Oct 24 (Reuters) - Nearly half of patients who completed 56 weeks of treatment with Orexigen Therapeutics Inc's (OREX.O) experimental obesity treatment, Contrave, lost at least 10 percent of their weight in a late-stage study and the drug also appeared to help cholesterol and blood sugar levels.

The drug demonstrated an even greater improvement in non- weight loss measures in patients considered to be at high risk of heart disease, according to data released on Saturday.

Orexigen released top-line data in July from a trio of Phase III trials showing Contrave met its primary goal of at least 5 percent weight loss compared with a placebo.

That data included all patients who began the studies, even those who discontinued the medicine at any point. The data presented Saturday included only those who completed 56 weeks of treatment, which the company called "a more clinically relevant number."

Orexigen also released data that looked at several secondary measures, such as impact on waist circumference, blood lipids and a marker for inflammation, as well as blood sugar levels in a separate trial of obese diabetics.

"We're very encouraged that all those things are going in the right direction," Dennis Kim, Orexigen's head of medical affairs who presented the new data at the Obesity Society scientific meeting in Washington, said in an interview.

Contrave is a pill that combines the antidepressant Wellbutrin, known generically as bupropion, with a sustained- release version of naltrexone, an opioid blocker used to treat alcoholism and other addictions.

New obesity treatments are needed for what has become a public health epidemic as obesity is a leading cause of diabetes, heart disease and many other serious medical problems, and the condition is rising at alarming rates.

The top-line data in July showed 48 percent of obese patients lost at least 5 percent of their body weight in one trial and 56.3 percent in a second study, compared with 16.4 percent and 17.1 percent on placebo.

Those differences are considered robust enough for likely FDA approval and the company said it was on track to apply for U.S. approval in the first half of next year.

But when looking only at patients who completed the 56-week study, the Contrave numbers jump to 61.8 percent and 75.8 percent compared with 23.1 percent and 21.7 percent on placebo.  Continued...

 
 

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