Boston, MA 06/12/2014 (wallstreetpr) – A bio-pharmaceutical company with a clear focus on obesity drug, Orexigen Therapeutics, Inc. (NASDAQ:OREX) announced that the drug regulator has extended time by three months for the review of the resubmitted NDA or New Drug Application for its drug Contrave. It has been directly reflected in the stock market where the stock was hammered by over 18% on Wednesday’s trading.
Delays Decision On Diet Drug
The company disclosed that the U.S. Food and Drug Administration or FDA has fixed September 11 for taking up its resubmitted NDA for its investigational medication drug Contrave meant for weight loss. Orexigen said that the pill has to be taken twice a day and is designed to cut appetite besides controlling cravings.
The obesity drug maker said that Contrave amalgamates bupropion, the dynamic component in the Wellbutrin’s antidepressant with the anti–addiction medicine naltrexone.
The new drug candidate, Contrave, is the third drug candidate meant for weight loss that was submitted to the drug regulator for approval in obesity treatment.
The company said that the FDA has indicated review extension is necessary to reach a deal on the post-marketing commitment related to the earlier agreed upon assessment of cardiovascular outcomes for the weight loss drug candidate. Orexigen said that the NDA resubmission package included interim CV outcomes data and safety from its continuing 8,900 patient Light Trial. There are also discussions about the package insert besides other obligations on posts-marketing are also going on.
Earlier Approval
Orexigen failed to get FDA approval in 2011 citing concerns on risk factors about cardiovascular. The company had to resubmit its application in December last year indicating that the drug fared well during the early study analysis to rule out undue risk of cardiovascular.
As many as 78 million adults were affected by obesity in the U.S. The drug regulator has also approved weight loss drugs of Vivus, Inc. (NASDAQ:VVUS) and Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) during the last few years. While Vivus generated sales of $9.1 million from Qsymia in its most recent quarter, Arena and its partner Eisai generated sales of $8.4 million from its drug Belviq, Both are weight loss drug.
Meanwhile, Orexigen Therapeutics, Inc. (NASDAQ:OREX)’s CEO indicated that it will work with the FDA expeditiously to finalize the review.
