Rejected Weight-Loss Drug Contrave Breathes Life into Orexigen - HealthNews

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San Diego-based drug maker Orexigen Therapeutics, manufacturer of weight-loss drug Contrave, has decided to proceed with a necessary study to get full approval from the FDA for consumer use.

Last year, Food and Drug Administration advisory committees reviewed and rejected two different weight-loss drug applications: Qnexa and Lorcaserin. Only one made it past committee: Orexigen Therapeutics Contrave. Then earlier this year, Contrave looked to get full approval from the FDA. But the REJECT stamp was used once again, due to concerns about long-term use and heart problems.

However, there was a small glimmer of hope. Orexigen Therapeutics received a letter from the FDA that called for a long-term study of the drug, saying specifically that, "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with [Contrave] does not adversely affect the drug's benefit-risk profile."

Contrave is a combination drug that "targets behavior and reward pathways in the brain." It combines the antidepressant Wellbutrin (bupropion) with naltrexone, an opioid blocker used to treat alcoholism and opiate addiction. It is one of the first drugs to address the issue of craving that many overeaters experience.

Results of late-stage clinical trials for Contrave showed that the drug quelled cravings and promoted weight loss, more than more than satisfying the effectiveness requirement of the Food and Drug Administration. (FDA guidelines suggest that any weight loss drug must reduce total body weight by at least 5 percent after one year to be called effective.)

During the trials, those patients who took Contrave experienced significantly greater weight loss than those who received a placebo, on average about 5 percent of body weight. In addition, Contrave reduced other risk factors such as waist circumference, midsection fat and triglycerides, while it improved levels of "good" HDL cholesterol and lowered blood sugar levels in patients with diabetes.

The most serious side effects experienced during the trials included two patients suffering a gallbladder infection and two patients experiencing a seizure. Only one patient reported heart palpitations, another experienced poor circulation in the limbs and one had vertigo. The most common side effects were nausea, constipation and headache.

The new trial, which should take two years, will enroll as many as 10,000 participants.  If they can get the results that the FDA requires, the drug could be ready for market as early as 2014.

21 Sep, 2011

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