The Food and Drug Administration (FDA) has approved two new weight loss drugs – marketed as Belviq and Qsymia – within the last 30 days. These are the first medications to be cleared by the FDA for marketing in the United States in 13 years.
According to FDA statements, these medications aim “to help obese and overweight Americans who have been unsuccessful in getting their weight under control with diet and exercise.”
The approval of these drugs will expand the treatment options available for the overweight and obese, but with modest weight loss and potential side effects, will consumers actually use them?
Far from being a quick fix, Qsymia and Belviq are prescription medications that are intended to be taken for the rest of a person’s life. “For many people, obesity is a life-long condition,” says Amy Egan, MD, MPH, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DEMP). “Qsymia and Belviq are considered life-long therapies.”
Lifestyle changes are also required. While the weight loss drugs help a person eat less and feel full with less food by controlling hunger and increasing satiety, weight loss relies on using them in combination with a healthy reduced-calorie diet and exercise.
Are you a candidate?
The medications are approved for adults (at least 18 years of age) with a body mass index (BMI) of 30 or greater (obese); or a BMI of 27 or greater (overweight) and at least one other weight-related condition, such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
Women who are pregnant or thinking of becoming pregnant should not take either of these medications as they can cause harm to the fetus. Women with reproductive potential are instructed to use effective contraception consistently while taking the weight loss medications.
How do they work?
The general weight loss mechanism of Belviq (pronounced BEL-VEEK) and Qsymia (pronounced kyoo sim EE uh) is to control hunger. That is, if you’re not hungry, you’ll eat less and lose weight. The medications are meant as a tool to help patients limit the amount of calories consumed, but it will be up to the patient to make healthy eating choices.
Belviq (trade name for the drug lorcaserin hydrochloride) is an oral weight loss drug that comes in a 10 mg tablet that is taken twice a day. The medication works by activating the part of the brain (serotonin 2C receptor) that controls hunger. It is manufactured by Arena Pharmaceuticals, Switzerland.
The safety and efficacy of Belviq were evaluated in three clinical trials which lasted from 52 to 104 weeks and included nearly 8,000 obese and overweight patients. All patients were expected to modify lifestyles to include a reduced calorie diet and exercise.
- Average weight loss in participants taking Belviq compared to the placebo group ranged from 3 percent to 3.7 percent
- In people without type 2 diabetes, about 47 percent lost at least 5 percent of their body weight compared to 23 percent of the placebo group
- In people with type 2 diabetes, about 38 percent lost at least 5 percent of their body weight compared to 16 percent of the placebo group
Common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation; and in diabetic patients are hypoglycemia (low blood sugar), headache, back pain, cough, and fatigue.
Qsymia (previously known as Qnexa) is a combination of two FDA-approved drugs, phentermine (indicated for short term weight loss) and topiramate (used for treatment of epileptic seizures and migraine headaches). Working together in an extended-release formula, phentermine acts to suppress appetite and topiramate increases satiety (feeling of fullness). It was developed by Vivus Inc. in Mountain View, California.
The safety and efficacy of Qsymia were evaluated in two clinical trials which included nearly 3,700 obese and overweight patients treated for up to one year. All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity.
- Average weight loss in participants taking Qsymia compared to the placebo group ranged from 6.7 percent (lowest dose) to 8.9 percent (recommended dose)
- Percent of participants who lost at least 5 percent of their weight was 62 percent (lowest dose), 70 percent (recommended dose), and 20 percent (placebo)
Common side effects of Qsymia are paresthesia (tingling of hands and feet), dizziness, altered taste sensation, insomnia, constipation, and dry mouth.
Availability and Cost
The weight loss medications have been approved for marketing but are not yet available. Qsymia is expected to be available at the end of 2012; estimated release of Belviq is early 2013, pending a review and final scheduling designation by the DEA. Both will be available by prescription only.
The cost of the medications has not yet been disclosed. A hint of pricing was given by the president of Vivus (developer of Qsymia), however, who suggested the price would be similar to the price of diabetes drugs, which is about $6 a pill. Most patients will probably have to pay the total cost, as insurance companies have generally not covered the cost of weight loss drugs.
The FDA approval of these two weight loss drugs helps to fill a void in treatment options for obesity and overweight, as few alternatives for weight loss assistance currently exist between diet and exercise programs and bariatric surgery. Long-term trials will be ongoing for both drugs to further study risk of heart attacks and strokes.
Source: “FDA approves Belviq to treat some overweight or obese adults,: FDA News Release, June 27, 2012; “FDA approves weight-management durg Qsymia,” FDA News Release, July 17, 2012; “Medications Taget Long-Term Weight Control,” FDA Consumer Update.