Orexigen stock falls after FDA extends review of obesity drug

Obesity-focused US biopharmaceutical company Orexigen Therapeutics (Nasdaq: OREX) says that the US Food and Drug Administration has extended its review of the resubmitted New Drug Application (NDA) for the company's investigational medication Contrave (naltrexone SR and bupropion SR; NB32), being evaluated for weight loss. The company’s shares dropped 15% to $5.80 in premarket trading today.

The new Prescription Drug User Fee Act (PDUFA) action date for NB32 has been set for September 11, 2014. The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32. The NDA resubmission package includes interim safety and CV outcomes data from the ongoing 8,900 patient Light Study. Discussions around the package insert and other post-marketing obligations are ongoing.

Michael Narachi, Orexigen chief executive, said: “We are working expeditiously with the FDA to finalize the review. We are encouraged by the high level of engagement with the FDA, and are confident that we can reach agreement on the remaining post-marketing obligation.”