Naltrexone/Bupropion Approved as Mysimba for Obesity in EU

March 27, 2015

The European Commission has granted marketing authorization for naltrexone HCl/bupropion HCl prolonged release (Mysimba, Orexigen Therapeutics) for the treatment of obesity, the company has announced. The marketing authorization applies to all 28 EU member states.

The exact indication is as an adjunct to a reduced-calorie diet and increased physical activity for the management of weight in adult patients (≥18 years) with an initial body mass index (BMI) of ≥ 30 kg/m2 (obese) or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related comorbidities (eg, type 2 diabetes, dyslipidemia, or controlled hypertension).

Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

In the United States, naltrexone HCl/bupropion HCl prolonged release was approved for the treatment of obesity in September 2014, where it is marketed as Contrave .

More Treatment Options for Obesity for Doctors in the European Union

This is the second obesity drug to be approved this week in Europe, on the heels of the marketing authorization for liraglutide (Saxenda, Novo Nordisk).

This gives physicians treating obesity in Europe two new therapeutic options.

They have long bemoaned the fact that they have not had access to any of the newer agents for weight loss that have been available in the United States.

Due to safety concerns, the European Medicines Agency rejected two agents that were cleared for use in weight loss in the United States in 2012: lorcaserin (Belviq, Eisai) and phentermine/topiramate (Qsymia, Vivus).

Prior to the approval of Saxenda and Mysimba, only orlistat was available to treat obesity in Europe; it is available without a prescription in a low dose (Alli, GlaxoSmithKline) or by prescription at a higher dose (Xenical, Genentech).


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