Contrave, New Drug for Obesity Approved by the FDA

contrave_r620x349It was just announced that the United States Food and Drug Administration (FDA) approved a new combinational pill for obesity known as Contrave. This drug is manufactured by Orexigen Therapeutics in California and will be distributed by Takeda Pharmaceuticals America.

Contrave is a unique combination of bupropion hydrochloride and naltrexone hydrochloride and comes in an extended-release tablet used to treat chronic weight problems like obesity. Although studies and clinical trials show Contrave to be a breakthrough drug, it is prescribed in conjunction with a reduced calorie diet and daily exercise.

At this time, Contrave is only approved for adults who have a Body Mass Index (BMI) of 30 or greater, which signifies obesity. However, it can also be prescribed to adults with a BMI of 27 or higher if they have at minimum, one weight-related condition such as Type 2 Diabetes, high cholesterol, or hypertension.

According to the US Centers for Disease Control and Prevention (CDC), more than 33% of adults in the United States are currently obese. Because of the excess weight, these individuals face a number of secondary problems such as those mentioned but also heart disease, stroke, and even certain types of cancers.

For more than 13 years, no drug had been developed to help with obesity but now, Contrave joins two other drugs used for this purpose approved by the FDA within the past two years. Belviq (lorcaserin hydrochloride) is distributed by Arena Pharmaceuticals and Qsymia (phentermine and topiramate) comes from Vivus.

As stated by Dr. Jean-Marc Guetter, director of the Division of Metabolism and Endocrinology Product associated with the FDA’s Center for Drug Evaluation and Research, obesity is still a huge public health problem. However, Contrave, in conjunction with healthy diet and regular exercise program provides people yet another weight management treatment.

Both of the drugs used to create Contrave, bupropion and naltrexone, are approved by the FDA in an extended release type of delivery system. On their own, bupropion is used to treat Seasonal Affective Disorder and depression, but it also helps people to stop smoking. On the other hand, naltrexone is used to treat dependency on opioids and alcohol.

To prove effectiveness and safety, Contrave was studied in several clinical trials. These trials consisted of approximately 4,500 obese and overweight participants, some with and some without major weight-related problems. For one year, these patients were treated with Contrave but also modified lifestyle.

In one of the clinical trials, patients without diabetes who took Contrave had a 4.1% greater chance of achieving weight loss over those receiving a placebo. For this trial, of the participants given Contrave, 42% had a 5% loss of body weight or more compared to just 17% for the group receiving placebo.

In a second clinical trial, which consisted of participants with Type 2 Diabetes, the average weight loss was 7% after one year of treatment. For this trial, of the individuals given Contrave, 36% had a minimum weight loss of 5% whereas only 18% of the placebo group experienced weight reduction.

Dr. Ronald Tamler, Director of Mount Sinai Diabetes Center at Mount Sinai Hospital in New York, states that Contrave has the ability to increase options for medical professionals who treat weight problems to include excessive weight and obesity. He goes on to say that Contrave is a useful alternative but goals of weight loss are only attainable with lifestyle modifications.

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