FDA Approves Another Weight Loss Drug

The U.S. Food and Drug Administration (FDA) has approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management. The drug is 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 must not be used during pregnancy because of increased risk of oral clefts (cleft lip with or without cleft palate) during the first trimester due to the topiramate component of the drug. Qsymia is also not for use in patients with glaucoma or hyperthyroidism because it can increase heart rate. The approval comes on the heels of the FDA's approval of Belviq (locaserin hydrochloride) last month as a weight-management aid. Qsymia, known as Qnexa during its development, is marketed by Vivus Inc.

Read more about Qsymia's journey to approval in Psychiatric News, here, here, and here.

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FDA Approves Belviq to Treat Some Overweight or Obese Adults

The FDA has approved Belviq (lorcaserin hydrochloride) for chronic weight managementas an addition to a reduced-calorie diet and exercise. The drug is 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) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

Belviq works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food. The safety and efficacy of Belviq were evaluated in three randomized, placebo-controlled trials that included nearly 8,000 obese and overweight patients, with and without type 2 diabetes, treated for 52 to 104 weeks. The drug’s manufacturer will be required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke.

The FDA is continuing to evaluate the phentermine/topiramate combination known as Qnexa for approval as a weight loss drug. Read more about it in the Med Check column of Psychiatric News here.

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