We previously reported that Contrave could gain approval from the FDA if Orexigen Therapeutics were able to demonstrate in a clinical trial that the treatment was not related to cardiovascular problems. Orexigen has now stated that recent discussions with the FDA have made them optimistic about the possibility of accelerating the regulatory review that is required before the treatment is approved.
The purpose of the trial, which has been referred to as The Light Study, is to evaluate whether individuals taking Contrave will develop any Major Adverse Cardiovascular Events (MACE) that individuals taking placebo medication do not develop or if there is any statistically significant difference in the incidence of such events between the two groups. Although the complete trial is likely to take a long time, the goal is to release an interim analysis of the data once the 87th MACE has occurred. To date 7000 individuals have been recruited and the aim is to recruit 9000 individuals before the end of this year. By having an increased rate of enrolment, the hope is that the interim analysis can be moved by up to two months.
Orexigen is prepared to resubmit the new drug application before the interim assessment, and then provide the analysis while the drug application is pending. If the FDA agrees to this, then it is possible that the review of their application could begin weeks or months before the interim analysis has been completed. This would of course be a valuable head start, as a standard review period for a medication is usually 10 months long.
Despite the fact that trials are both time-consuming and expensive, Orexigen is yet to abandon hope on getting approval for Contrave. We believe that this is a reflection of the fact that the noted cardiovascular risks in the past were not significant for the company to abandon the expensive quest to get Contrave approved.