Contrave highlights data protection conundrum facing CV outcomes studies
After more than three years and multiple setbacks related to establishing Contrave naltrexone/bupropion's cardiovascular safety, Orexigen Therapeutics Inc.'s obesity drug finally won FDA approval this month. But concerns over confidentiality of an interim analysis scuttled Orexigen's attempts to use a single CV outcomes trial to fulfill pre- and postmarket safety requirements.
The conundrum left the company and partner Takeda Pharmaceutical Co. Ltd. on the hook to conduct a postapproval study.
Contrave is the most recent of at least three products to run into a snag with plans to use a single CV outcomes trial with an interim analysis, which could be a faster and cheaper way of meeting pre- and postapproval CV safety requirements than running separate trials.
Indeed, how to prevent interim disclosures of data from harming ongoing CV trials was the subject of a public meeting held by FDA last month. The agency and stakeholders discussed several methods for preserving the integrity of such trials, including targeting the interim data readout near full enrollment to reduce the impact of accidental disclosure and using data access plans to limit the chance of improper disclosure.
The discussion focused on diabetes trials, but is applicable to other settings in which FDA may require both pre- and postapproval CV outcomes data, such as obesity.
In 2008, FDA published guidance requiring sponsors of new