New Drug Against Obesity Authorized In USA
The American sanitary authorities give their green light to Contrave ® the fourth patent drug against obesity and overweight. What is it necessary to think of it?
Food and American Drug Administration (FDA) has just given its green light to the marketing of the association bupropion/naltrexone – a specialty marketed under the mark Contrave ®). It is a relative surprise: the same FDA had initially rejected the marketing authorization for the same molecule in February, 2011. It feared then a possible long-term cardiovascular toxicity of this molecule for the overweight and obese patients. However new results, reassuring, of the try of cardiovascular safety “Light Study”, led with 9000 people, modified it.
The American agency however approved the treatment by this molecule only at the adults whose body mass index is higher than 30. It also approved it at the adults with a BMI lower or equal to 27 provided that these people have at least another risk factor associated with their weight (arterial hypertension, type 2 diabetes or hypercholesterolemia).
Important note: a warning will appear on the note of drug to alert the healthcare professionals and the patients of the greater risk of suicidal thoughts associated with the use of the bupropion. Moreover, the grave neuropsychiatric events brought back with this molecule (marketed under the mark Zyban®) in the smoking cessation.
Four molecules in the USA
The marketing authorization also comes along with an obligation to realize several studies “post-marketing”, of which one on the cardiovascular risks. The bupropion/naltrexone association can indeed increase the arterial pressure and accelerate the heart rhythm. The people victims of a myocardial infarction or a stroke had been excluded from clinical trials. It was the same of those presenting dangerous arrhythmias or cardiac insufficiency. It was the same of those presenting dangerous arrhythmias or cardiac insufficiency.
The site Medscape.com explains that From now on four drugs against the obesity are available in the United States.
Besides Contrave®, the anti-obesity drugs already marketed in the United States is the orlistat (Alli®, GlaxoSmithKline) and Qsymia® (Vivus). It is here about an association of phentermine, a by-product of amphetamine used to reduce the appetite, and topiramate, an anti-epileptic (very close combinations are estimated in the weaning of the cocaine). There is also Belviq® (Arena Pharmaceuticals) which showed a certain efficiency in the addiction in the nicotine or the cocaine. These molecules, which, a priori, concern more the neurology than the fight against obesity, were authorized in this indication only on the condition of very elaborate post-marketing studies.