The agency cleared the pill Qsymia for adults who are obese or overweight.
The Food and Drug Administration on Tuesday approved a replacement weight loss drug from Vivus Inc. that several doctors think about the foremost effective therapy in an exceedingly new generation of anti-obesity pills designed to assist patients safely shed pounds.
The agency cleared the pill Qsymia for adults who are obese or overweight and have a minimum of one weight-related condition like high blood pressure, diabetes or high cholesterol.
Patients taking Qsymia for a year lost six.7 % of their body weight in one study and eight.9 % in another study, the FDA said. That was over 2 alternative weight loss pill recently reviewed by the FDA.
Despite its spectacular performance in clinical trials, Qsymia isn’t precisely a scientific breakthrough, and its development underscores the slow pace of analysis for obesity treatments.
The drug is really a mix of 2 older medication that have long been known to assist with weight loss: phentermine and topirimate.
Phentermine could be a stimulant that suppresses the appetite, and has long been used for short-term weight loss. Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, that creates folks feel a lot of satiated when eating.
Researchers say the innovation of Qsymia lies in targeting multiple brain signals that drive folks to overeat.
“We currently recognize there are multiple pathways that confirm what proportion energy we tend to soak up daily,” said Dr. Tim Garvey of the University of Alabama at Birmingham. “If you intervene on one pathway it s exhausting to create abundant of a distinction, you actually got to attack multiple mechanisms to urge a pronounced result.”
Garvey helped conduct many pivotal trials of the drug. Qsymia is that the second weight loss drug approved by the FDA in but a month, following Arena Pharmaceutical s pill Belviq in late June. Previously the agency had not approved a replacement drug for long-term weight loss since 1999.
With U.S. obesity rates nearing thirty five % of the adult population, several doctors have known as on the FDA to approve new weight loss treatments. however an extended line of prescription diet pills are related to dangerous aspect effects, notably heart issues.