Orexigen Announces Successful Interim Analysis of Contrave Light Study, Will Resubmit Contrave NDA to FDA

Orexigen Therapeutics

today announced successful results of the interim analysis of the Light Study. Based on these results, the Company will resubmit the Contrave® New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in the next few weeks with potential approval by June 2014.  "The interim analysis of the Light Study clearly achieved the goal set by the FDA," said Michael Narachi, CEO of Orexigen.  "The resubmission will contain an unprecedented amount of cardiovascular outcomes data for an obesity therapeutic, and we are confident these data will support a favorable benefit:risk assessment for Contrave." The FDA previously agreed that if the interim analysis meets the specified criteria to exclude cardiovascular risk, Contrave could be approved. The pre-specified criteria for the interim analysis is to exclude a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events (MACE) in patients receiving Contrave as compared to placebo. In addition to meeting the pre-specified criteria for excluding cardiovascular risk, no new safety signals