The FDA announced its approval of the weight loss drug, Qsymia (previously known as Qnexa), which is only the second new obesity drug to be approved this century. In February, an advisory voted 20-2 to approve the drug in a preliminary vote. The drug makers, Vivus, had proposed the name Qnexa in the drug’s application, but the FDA decided that the name may be too similar to other approved drugs, and the company eventually went with Qsymia to reduce any potential for medication errors. Qsymia is a combination of two FDA-approved drugs: phentermine, a stimulant related to the amphetamines that suppresses the appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight-loss side effects.
Qsymia will be available by prescription to overweight and obese people who have at least one weight-related health problem such as Type 2 diabetes, high cholesterol, or high blood pressure. Vivus presented data indicating that in combination with a healthy diet and exercise, the drug helped patients to shed about 10 percent of their body weight, an amount shown to have health benefits.
The approval has both critics and supporters. With more than a third of the adult population obese, it is exciting to have another tool to help people lose weight; however, the drug has been shown to have negative side effects. The most common side effects are tingling of the hands and feet, dizziness, insomnia, constipation, and a change in taste sensation and dry mouth. Qsymia was previously rejected by the FDA in 2010, under the name Qnexa. The drug was associated with mental fogginess, elevated heart rate and birth defects. Vivus then resubmitted the drug application with additional safety data. In two studies of safety and efficacy, after a year of taking the drug, patients lost 7–9 percent of their body weight, and 62–69 percent of study participants lost 5 percent of their body weight. In comparison, just 20 percent of patients taking a placebo lost 5 percent of their body weight.
Just last month, the FDA approved the first new weight loss drug in more than 13 years, Belviq. You can read more about Belviq here.
Industry & Innovation