Orexigen gets FDA dispute response supportive of faster path to Contrave review

The USA’s Orexigen Therapeutics (Nasdaq: OREX) saw its shares jump 9.3% in early trading yesterday, after the company said it has received a response to a formal dispute resolution request (FDRR) from the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) relating to the stalled New Drug Application for its obesity drug candidate Contrave (naltrexone SR/bupropion SR).

The response indicates that CDER highly supports further discussions regarding a faster path to resubmission of the Contrave NDA. Orexigen plans to explore with the FDA the possibility of resubmitting the diet pill’s 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.

Light Study enrollment surpasses 7,000 patients