OCU opposes that the "MYSIMBA" drug be allowed to be sold to treat overweight

On 19 December the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended granting the marketing authorisation for Mysimba (naltrexone / bupropion) indicating it for weight loss in overweight or obese adults.

Mysimba is a combination of two active ingredients (bupropion and naltrexone), each of which is approved for other conditions. Bupropion is an amphetamine used as a treatment for giving up smoking and for depression. Included among its adverse effects are seizures and the occurrence of hypertension. Naltrexone is used for treating alcoholism and addiction to opiates such as heroin. Possible side effects include gastrointestinal disorders, insomnia, restlessness, joint pain and headaches. Both substances act on the parts of the brain that control food intake and energy balance and also reduce the effects in the part of the brain that controls the pleasurable sensation associated with food intake. However the exact mechanism by which these substances function is unknown.

In recent years many medications for weight loss have been withdrawn from the market due to serious adverse effects (including amphetamine derivatives similar to Mysimba). The results of the pivotal studies with Mysimba show that its effectiveness in weight loss is negligible and only clinically relevant if those taking the drug also change their lifestyle by sticking to a low calorie diet and engaging in physical activity.

Despite being aware that overweight and obesity are a major risk factor for a number of chronic diseases, including diabetes and cardiovascular disease, we consider the extremely modest effect (if any) in the loss of weight that is achieved through pharmacological treatment does not justify the disproportionate risk of adverse side effects that these patients would be exposed to, especially considering that the lost weight is regained after the finishing the diet and treatment. Therefore OCU believes that the benefits of this drug for patients and public health, do not outweigh the risks.