The dissatisfaction of the National Medicines Safety Agency (ANSM) has not changed anything. The marketing of Mysimba appetite suppressant has been approved by the European Commission. This green light is the logical continuation of a first agreement obtained on December 19 by the European Medicines Agency.
This anti-obesity treatment, called Mysimba in Europe and Contrave in the United States, combines two molecules, naltrexone, used to treat addictions (alcohol, drugs), and bupropion used as an antidepressant. It would act on key circuits in the brain: the hypothalamus, linked to food intake and energy expenditure, and the reward system. This targeting would make it possible to lose 4 to 5% of one’s weight, according to the American laboratory Orexigen Therapeutics which manufactures it.
Nothing should oppose the marketing of this drug, which will be available on prescription for adults suffering from overweight, obesity or associated pathologies (hypertension, diabetes or cholesterol). However, the Mysimba is far from unanimous.
A controversial slimming pill
France’s strong opposition by the voice of the National Medicines Safety Agency (ANSM) will not have been heard. In addition to the doubts expressed about its slimming effectiveness, it considered that the marketing of this appetite suppressant was not desirable because “the safety of the product was not sufficiently established”. It highlighted the neuropsychiatric (depression, suicide, etc.) and cardiovascular risks associated with the long-term use of Mysimba.
50% of participants in a clinical trial would have abandoned the experiment due toside effects, according to Joseph Emerich, director of drugs in cardiology at the ANSM, taken over by AFP. The final results of this clinical trial are not yet known.
Supervision in France
No date for the marketing of Mysimba in France has yet been advanced. But the ANSM takes care to specify that its marketing will be subject to precise supervision. “We will in particular discuss prescription conditions, monitor sales figures and inform health professionals,” Joseph Emerich told AFP.
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