FDA Approves New Obesity Drug

The US Food and Drug Administration (FDA) approved the third new prescription drug for obesity since 2012.

Contrave_cropThe drug, Contrave, to be used along with a low-calorie diet and exercise regimen, was approved for treatment of obese adults (body mass index [BMI] of 30 or greater) or overweight adults (BMI of 27 or greater) with a weight-related condition such as high blood pressure or Type 2 diabetes, wrote the Los Angeles Times.

Given that about one-third of American adults are obese, there is a strong need for weight loss approaches that go beyond diet and exercise but are not as drastic as surgery.

Contrave, which is manufactured by Orexigen Therapeutics Inc. of La Jolla, California, combines naltrexone, a drug used to treat alcohol and opioid dependence, and bupropion, which is prescribed for depression, seasonal affective disorder, and smoking cessation.

In a press release, the FDA wrote that the effectiveness of Contrave was evaluated in multiple clinical trials that included approximately 4500 obese and overweight patients with and without significant weight-related conditions treated for 1 year. All patients received lifestyle modification that consisted of a reduced-calorie diet and regular physical activity.

The New York Times reported that patients without diabetes who took Contrave for 1 year had an average weight loss of 4.1% beyond those receiving a placebo. About 42% of those getting Contrave lost at least 5% of their weight, compared with 17% of patients in the placebo group.

In a trial of patients with Type 2 diabetes, 36% of Contrave-treated patients lost at least 5% of their weight, compared with 18% of patients who received a placebo, the FDA said.

However, although these weight losses can be meaningful, they won’t happen if consumers rely on pills alone, Adam Tsai, the public affair committee of the Obesity Society, told USA Today. “The ideal candidate for a drug to treat obesity is someone who uses the drug as a tool, along with diet and exercise,” said Tsai.

According to the New York Times, 2 obesity drugs approved in 2012 (the first new prescription obesity drugs in 13 years) have had disappointing sales. Those drugs are Qsymia, which is sold by Vivus, and Belviq, which is from Arena Pharmaceuticals and Eisai.

Analysts, doctors and company executives say the drugs might not be selling well because many doctors and many obese people do not think of obesity as a disease to be treated by medicine.

Medicare, most state Medicaid programs and some commercial insurers do not pay for the drugs, which have been priced at upwards of $200 a month, wrote USA Today. Doctors and patients are cautious about safety because of problems with previous weight loss drugs. And for many people, the weight loss is modest.

However, Reuters wrote that analysts expect Contrave’s US sales to pass those of Belviq and Qsymia by 2016.

Newsmax Health reported that an advisory panel to the FDA concluded on September 11 that Novo Nordisk’s drug liraglutide (Victoza) is safe and effective enough to warrant approval for use in chronically obese patients with at least 1 weight-related health issue. Liraglutide is already approved to treat Type 2 diabetes.

The FDA did not approve Contrave for treatment of obesity in 2011 because there were signs that it slightly raised patients’ pulse rates and blood pressure, wrote the New York Times. Orexigen then conducted a study of about 9000 patients to demonstrate that the drug did not raise the risk of heart attacks. That study is continuing, but interim results have apparently satisfied the regulators.

A boxed warning will alert healthcare providers to an increased risk of suicidal thoughts and behaviors associated with antidepressant drugs.

“Contrave can cause seizures and must not be used in patients who have seizure disorders,” said the FDA news release. “Contrave can also raise blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure.”

The drug should also not be used in patients who have eating disorders, such as bulimia or anorexia nervosa, the FDA said.

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