Drug news
FDA agrees with Orexigen the form of CV risk trial for Contrave
The FDA had requested a cardiovascular outcomes trial (CVOT) for Contrave (naltrexone HCl/bupropion)which Orexigen had rejected. After a meeting with the FDA the form of the CVOT has been agreed. The trial will take two years to complete and will be conducted with obese patients who have CV risk. Submission to the FDA can be made on the basis of an interim analysis. The trial will initiate in the first half of 2012 and a potential application for approval to the FDA will be made in 2014
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins