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FDA Approves 2nd New Weight-Loss Drug
Date:7/18/2012

By Steven Reinberg
HealthDay Reporter

TUESDAY, July 17 (HealthDay News) -- For the second time in less than a month, U.S. drug regulators on Tuesday approved a new weight-loss medication.

Qsymia -- formerly dubbed Qnexa -- is a combination of the drugs phentermine and topiramate, and is manufactured by the pharmaceutical firm Vivus Inc.

"Obesity threatens the overall well being of patients and is a major public health concern," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an agency news release issued late Tuesday. "Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition."

The drug is approved only for the obese (people with a body-mass index, or BMI, of 30 or above) or overweight people (body mass 27 or higher) who also suffer from conditions such as hypertension, type 2 diabetes or high cholesterol. It will be available in a standard dose but also a higher dose "for select patients," the FDA said.

Last year, a study funded by Vivus found that obese patients taking Qsymia lost an average of 22 pounds over a year, while also lowering their blood pressure and cholesterol levels.

On June 27, the FDA gave its OK to another weight-loss drug, Belviq (lorcaserin), which was approved for obese adults who have high blood pressure, high cholesterol or type 2 diabetes, and is to be used in combination with a low-calorie diet and exercise.

The back-to-back approvals followed a 13-year stretch in which the FDA did not approve any new medications to help people struggling with overweight or obesity to lose unwanted and unneeded pounds.

In May, a study presented at the European Congress on Obesity in Lyon, France, found that volunteer
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