FDA Approves New Weight-Loss Pill

09/11/2014 11:38 AM | Gina Ulery (Administrator)
For the third time in about two years, the Food and Drug Administration has approved a new weight-loss pill.

Contrave got FDA approval Wednesday. The medication is made by Orexigen Therapeutics Inc., San Diego, and will be marketed by Takeda Pharmaceutical of Japan. It joins some older drugs and two newer pills, Qsymia and Belviq, as options to help adults battle their bulges.

All of the new drugs work by decreasing appetite and all have some side effects and drawbacks, though they differ. None promise massive weight loss.

"Obesity continues to be a major public health concern," the FDA's Jean-Marc Guettier said in a press release. "When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option."

Like its competitors, Contrave is approved for people who are obese or who are overweight and also have weight-related health problems, such as diabetes.

Contrave is a combination of two drugs: naltrexone, which is also is used to treat alcohol and drug dependence, and bupropion an antidepressant also used as a smoking cessation treatment.

It will come with a warning that it might increase suicidal thoughts. Other possible side effects include increases in blood pressure and heart rate, FDA says.

In trials, patients taking Contrave lost 2% to 4.1% more weight than those taking placebo. Between 36% and 42% lost at least 5% of their body weight.

In Belviq's studies for the FDA, average losses were 3% to 3.7% over placebo; for Qsymia, average losses were 6.7% to 8.9% over placebo.

Such weight losses can be meaningful, but they won't happen if consumers rely on pills alone, says Adam Tsai, a Denver internist who chairs the public affair committee of the Obesity Society, a group representing weight loss experts.

"The ideal candidate for a drug to treat obesity is someone who uses the drug as a tool, along with diet and exercise," says Tsai, who has no ties with drug makers.

So far, the other new pills have not been big sellers – considering that more than a third of U.S. adults, 78.6 million, are obese, according the federal Centers for Disease Control and Prevention.

One reason: Insurers have been slow to cover the treatments, which have been priced at upwards of $200 a month. Manufacturers have offered discounts to encourage consumers to try them.

Patients filled about 138,000 prescriptions for Qsymia in the second quarter of 2014, according to drug maker Vivus Inc.

Prescription numbers for Belviq were about 110,000 in the same period, according to Arena Pharmaceuticals Inc., which makes the drug. Belviq is marketed by Eisai Co.

Just 2% of people who are candidates for drug treatment are using a drug now, says Craig Audet, senior vice president for operations at Arena. That's a lot of room for growth, he says, and having a third drug approved just "gets more voices out there" talking about the pharmaceutical options.

Audet says insurers are increasingly paying for the medications, with 60% of privately insured patients now getting some coverage, up from 30% when Belviq was introduced in 2013.

In the past, some obesity drugs have been linked to serious heart problems and pulled from the market.

The makers of Contrave, Belviq and Qsymia have all agreed to conduct long-term heart safety studies and report the results to FDA.

Source: http://www.usatoday.com/story/news/nation/2014/09/10/fda-approves-weight-loss-pill/15426453/


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