The Food and Drug Administration (FDA) approved Qsymia, the second new diet drug in a month, and the most effective of the weight-loss pills that the agency has considered in recent years.
Qsymia, made by Vivus Inc., receives market approval on the heels of Arena’s Belviq (lorcaserin), the diet pill cleared by the FDA in late June. Before these two new drugs, the last prescription weight-loss pill to be green-lit by the government was Roche’s Xenical (orlistat) 13 years ago, in 1999.
Diet pills have had a spotty history with the FDA, largely because of safety problems involving the heart. Other drugs — most notably fenfluramine, used in the popular weight-loss combination fen-phen — have been withdrawn from the market for such hazards, and new drugs have had to clear a high bar for consideration.
(MORE: A Brief History of Diet Pills and the FDA)
The new pill, formerly known as Qnexa (the FDA asked Vivus to change the name to avoid confusion with another drug on the market), will be available by the fourth quarter of this year, according to the company’s president, Peter Tam. Here’s what you need to know.
Who can use Qsymia?
The drug is approved for obese adults with a body mass index, or BMI, of 30 or higher. It can also be used by overweight adults, with a BMI of 27 or higher, if they have at least one weight-related condition such as high blood pressure, Type 2 diabetes or high cholesterol.
How does it work?
Qsymia is a combination of two existing drugs: phentermine, an appetite-suppressing stimulant that has long been used for short-term weight loss, and topiramate, an anti-seizure medication used to treat epilepsy that makes people feel fuller after eating. Some doctors have already been prescribing the two drugs together for weight loss. Researchers say the key to Qsymia’s success is that it targets multiple brain pathways that trigger overeating.
How much weight will I lose?
It varies. In clinical trials, overweight and obese patients taking Qsymia for a year lost differing amounts of weight: on average, patients taking a middle dose of the drug lost 8.4% of their body weight; on a higher dose, patients lost 10.6%.
Qsymia: FDA Approves Another New Diet Drug | Healthland | TIME.com