Orexigen's Contrave Light Study Meets Specified Criteria - Quick Facts

(RTTNews) - Orexigen Therapeutics, Inc. (OREX), Monday reported successful results from the Light Study's interim analysis, based on which it would resubmit the Contrave New Drug Application to the United States Food and Drug Administration or FDA, in a few weeks, with approval expected by June 2014.

The FDA previously said Contrave could be approved if the interim analysis meets the specified criteria to exclude cardiovascular risk. The pre-specified criteria for the interim analysis excluded a hazard ratio of 2.0, using the upper bound of the 95% confidence interval, for excess risk of major adverse cardiovascular events or MACE in patients receiving Contrave when compared to placebo. Additionally, no new safety signals were observed, the company said.

Orexigen has licensed North American Contrave rights to Takeda Pharmaceuticals. The company owns rights in Europe and throughout the rest of the world, excluding North America, and is looking for a partner to commercialize Contrave in those areas. In October, the company submitted a Marketing Authorization Application for Contrave to the European Medicines Agency.