FDA Okays New Weight-Management Drug Contrave

The U.S. Food and Drug Administration gave a green signal to a new drug 'Contrave' for the treatment of weight management.

In a latest announcement, the FDA panel revealed that it had approved a new weight management drug Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets). The drug is used as a treatment option for chronic weight management along with reduced calorie diet and physical activity.

The newly-approved drug is meant to be used by adults with a body mass index of 30 or more or adults with BMI of 27 or more who also have at least one weight-related condition that includes hypertension, type-2 diabetes or high cholesterol. The Centers for Disease Control and Prevention stated that one-third of the U.S. adults are obese.

"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. "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."

Contrave is a mix of two drugs approved by the FDA panel. The two drugs are naltrexone (meant to treat alcohol and opioid dependence) and bupropion (used to treat depression and seasonal affective disorders and an aid to smoking cessation treatment).

Using multiple clinical trials, the researchers evaluated the effectiveness of the drug. The trial included 4,500 obese and overweight patients with or without weight-related conditions treated for a year. They all received lifestyle modifications that needed reduction in calorie diet and regular physical activity.

Those without diabetes had an average of 4.1 percent of weight loss when compared to the use of placebo, at one year. Nearly 42 percent of those treated with Contrave lost 5 percent of body weight as compared to 17 percent of those who were treated with placebo.

Another trial showed that, people with type-2 diabetes lost an average of 2 percent of weight over the use of placebo at one year. Also, 36 percent of those treated with Contrave lost 5 percent of body weight when compared to 18 percent of those treated with placebo.

Those using this new drug should get themselves evaluated after 12 weeks to ensure the treatment is working. Due to bupropion, Contrave comes with boxed warning to caution health experts and patients on the risk of suicidal thought and behaviors. Apart from this, the drug is also known to cause seizures, and must be avoided by those who have seizure-related disorders.

Also, the drug is known to raise blood pressure, heart rate and should be avoided by those with uncontrolled hypertension. The common adverse reactions include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea. FDA demanded a few post marketing requirements

The newly approved drug Contrave is distributed by Takeda Pharmaceuticals America Inc. of Deerfield, Illinois for Orexigen Therapeutics, Inc. of La Jolla, California.