FDA extends review of Orexigen weight-loss drug

The FDA has extended its review of the new drug application for NB32, an investigational medication developed by Orexigen Therapeutics, Inc. being evaluated for weight loss; it has been extended until September 11.

This 3-month extension for the resubmitted application provides time for an agreement to be reached on the post-marketing obligation for continued evaluation of cardiovascular (CV) outcomes, the company wrote in a press release.

A fixed-dose combination of bupropion sustained-release (SR) and Orexigen’s proprietary SR version of naltrexone, NB32 is seeking approval for appetite reduction, cravings control, metabolism boost and regulation of eating behaviors.

Interim safety and CV outcomes data from the ongoing Light Study — a multi-center, randomized, double-blind, placebo-controlled trial of 8,900 patients — are included in the resubmission.

Package inserts for the obesity therapeutic and other post-marketing obligations are also still under discussion, according to the company’s press release.

The FDA had previously agreed on criteria for the interim analysis, to exclude HR of 2.0, using the upper bound of the 95% CI, for excess risk of major adverse cardiovascular events with the drug compared to placebo.

“We are working expeditiously with the FDA to finalize the review,” Michael Narachi, CEO of Orexigen, said in the release. “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.”

Orexigen Therapeutics' obesity drug Contrave was rejected by the FDA in January 2011.

For more information: Orexigen Receives Three Month Extension of FDA NB32 Review