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Contrave has been approved for prescription in the United States. While this is great news for overweight patients in the US who struggle to lose weight through exercise and calorie restriction, it remains to be seen whether this product will get the green light in the EU. Contrave is currently being considered by the European Medicines Agency and we expect a decision before the end of 2014. We are aware that the EMA has recently requested more information on the risks versus outcomes. This is not unusual and should  not be taken as a negative signal.

The medication has been approved by the FDA with a number of provisos. First of all, an extensive post marketing study is required on the cardiovascular outcomes. Initial results of the Light Study trial have previously been reported here and those were favourable. However, it has been noted that blood pressure and heart rate can increase while taking Contrave so a much longer term study is required to ensure that seriously detrimental cardiovascular side effects are not observed. A further study on the effect that Contrave has on cardio conduction has also been ordered, as well as drug interaction studies.

Contrave has the potential to cause suicidal thought and other psychiatric side effects. Clinicians will need to be vigilant for any side effects and will need to screen out patients who may be prone to these side effects. Blood pressure must be monitored on a regular basis and patients with uncontrolled high blood pressure would be unsuitable candidates. Anyone who has not lost at least 5% of bodyweight within 3 months should discontinue the medication as the risks associated with the medication may outweigh any potential benefit.

We desperately need more options within our pharmaceutical armamentarium for talking obesity and the addition of Contrave would be helpful, even if it is definitely not suitable for many people.

You can read more information about the FDA approval of Contrave here.

Recent announcements by Orexigen suggest that the much-anticipated results from the Light study will not disappoint. This is exciting news as positive outcomes will significantly aid the approval of Contrave in the US and EU.

The Light study is a clinical trial utilising a double blind, placebo-controlled design in a sample of 8900 patients. In order to take part in the study, the participants must be above 45, have a BMI above 27 and believed to be at risk of cardiovascular disease. The research is expected to be completed by 2017 and is currently being conducted in 264 centres. The key purpose of the study is to investigate whether the active ingredient in Contrave (so-called NB-32) has a negative impact on major adverse cardiovascular events that could consequently lead to non-fatal strokes, non-fatal myocardial infarction and even cardiovascular death.

To date, Orexigen has presented optimistic results from an interim analysis, which suggests that the risks relating to cardiovascular risks are low enough to meet regulations set out by FDA and EMA. Given that previously published studies have indicated that the other noted side effects appear to be fairly mild (such as headache, insomnia and nausea) it appears that the approval of Contrave is yet to be seriously challenged.

Although many medical experts are keen to avoid pre-mature excitement, several agencies are predicting that the approval of Contrave is likely to occur in the US as early as 2014. It is expected that this will be followed by approval in the EU, with the potential delay being attributed to the conservative approach the European Medicines Agency (EMA) is known to adopt.

In addition to the Light study and previous studies, it is worth noting that the optimistic outlook on the approval of Contrave rests on the observations that FDA has not engaged a public advisory committee. This is noteworthy, as the public advisory committees that were engaged during the Arena Pharmaceuticals and Vivus Inc applications for obesity treatments were pinpointed as a pivotal obstacle that delayed the approval.

We are not surprised to read about these analyses and will keep you posted on any relevant developments.