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by Marijana Domazet, Monday, March 10, 2014 | Categories: Contrave

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.





 
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