FDA approves Qsymia, weight-loss drug for US
The FDA has announced it has approved a new weight-loss drug, called Qsymia, expanding the range of medical options available for obese Americans. Another drug was approved last week, called Belviq, by Arena Pharmaceuticals and before these two drugs, no new prescription weight-loss drugs had been approved by the FDA in 13 years.
Qsymia has been approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition, such as high blood pressure, type 2 diabetes or high cholesterol. Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation.
Two randomised, placebo-controlled clinical trials evaluated the safety and efficacy of Qsymia. These trials included approximately 3,700 obese and overweight patients with or without significant weight-related conditions treated for one year. The results show that after one year of treatment with the recommended daily dose of Qsymia, patients had an average weight loss of 6.7% and for those who tested the highest daily dose, their average weight loss rose to 8.9%.
“Obesity threatens the overall well being of patients and is a major public health concern. 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.”
Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
According to the Centers for Disease Control and Prevention, over one-third of adults in the United States are obese. Qsymia, developed by Vivus of Mountain View, California, is expected to be available in the fourth quarter, although the price is yet to be disclosed.
FDA approves Qsymia, a weight-loss drug (New York Times)
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