SAN DIEGO, Nov. 25, 2013 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) 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 were observed.
"Takeda is excited about this major milestone for Contrave," said Doug Cole, President of Takeda Pharmaceuticals U.S.A., Inc., Orexigen's partner for Contrave in North America. "Takeda is pleased to partner with Orexigen to develop a therapeutic option that has the potential to help patients achieve meaningful and sustained weight loss over time."
Conference Call This Morning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the interim analysis results. The live call may be accessed by phone by calling (888) 895-5479 (domestic) or (847) 619-6250 (international), participant code 36202424. The webcast can be accessed live on the Investor Relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.
About the Light Study
The Contrave Light Study is a double