Orexigen Therapeutics Receives Positive Dispute Response from FDA for Contrave
Orexigen Therapeutics (NASDAQ: OREX) today announced that it has received a response to a formal dispute resolution request (FDRR) from the United States Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER).
The response indicates that CDER highly supports further discussions regarding a faster path to resubmission of the Contrave® (naltrexone SR / bupropion SR) New Drug Application (NDA). Orexigen plans to explore with the FDA the possibility of resubmitting the Contrave NDA in advance of the interim data from the Light Study, the cardiovascular outcomes trial evaluating Contrave. Under this scenario data from the planned interim analysis would be provided during the anticipated review period. Although procedural details need to be addressed, the Company is optimistic that these discussions could result in a faster path to resubmission of the Contrave NDA.
Orexigen also announced that it has surpassed its goal to enroll 7,000 patients in the Light Study and plans to enroll approximately 9,000 patients through the end of 2012. With the resulting increase in