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