FDA Okays Weight-Loss Pill Contrave

The Food and Drug Administration has approved Orexigen Therapeutics Inc.'s weight-loss pill Contrave. This is the third weight-management medication that the agency has approved in the past two years.

Qsymia and Belviq are the other two drugs that help obese and overweight people manage their weight. The new drug Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) is for adults with a body mass index (BMI) of 30 or greater or BMI 27 plus chronic illness such as hypertension or diabetes.

The federal agency said that the drug should be used along physical activity and low-calorie diet. Contrave has two FDA pproved drugs- naltrexone and bupropion. FDA said that Naltrexone is used to treat alcohol dependence, while Bupropion is given to people with depression and those trying to quit smoking.

"Obesity continues to be a major public health concern," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research, according to a news release. "When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition."

The safety and efficacy of the drug combination was evaluated in 4500 patients. All participants were obese or overweight and were all put under a low-calorie diet and exercise routine for about a year.

The researchers found that people taking Contrave lost 2 percent to 4.1 percent more weight than people using placebo. Around 36 percent to 42 percent of participants lost around five percent of their body weight.

The new drug scores poor than its competitors such as Belviq, which registered average weight loss of about three to seven percent over placebo. Clinical trials for Qysmia showed that its use led to weight loss of about 6.7 percent to 8.9 percent over placebo, USA Today reported.

Contrave will carry a boxed warning. The drug might increase suicidal thoughts and behaviors among users. Other side effects include a change in heart rate.

A third of the U.S. population is obese. Still, weight loss drugs such as Belviq and Qsymia haven't had much success. One reason for their low sales is their price has prevented insurers from covering cost of drug-related treatment for obesity, according to USA Today. Currently, just two percent of obese people - who could benefit from these medications - use these options.

FDA said that it requires some post-marketing studies to assess Contrave's long-term effect on human health. The drug is distributed by Takeda Pharmaceuticals America Inc.