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Orexigen resubmits Contrave to FDA

Orexigen Therapeutics Inc. (Nasdaq: OREX) said Wednesday that it resubmitted to regulators its application for the potential weight loss treatment Contrave.

The La Jolla company expects the Food and Drug Administration to take about six months with its review.

The FDA refused to approve Contrave in 2011, citing concerns over cardiovascular risk. The pill combines bupropion, the active ingredient in the antidepressant Wellbutrin, with the anti-addiction drug naltrexone.

Orexigen conducted more research and announced last month that the drug fared well in an early analysis of data from a study designed to rule out excessive cardiovascular risk in overweight and obese patients. It said the FDA had agreed that Contrave could be approved if an early analysis of the study data met specific criteria to exclude cardiovascular risk.

Orexigen has already applied for marketing approval for the drug in Europe. It has licensed North American rights for Contrave to Japanese drugmaker Takeda Pharmaceuticals.

Orexigen has no products on the market, and Contrave its lead candidate.

Since rejecting Contrave, the FDA has approved the obesity drugs Qsymia from Vivus Inc. and Arena Pharmaceuticals Inc.'s Belviq, after initially rejecting both of those drugs as well.

Orexigen shares slipped 16 cents, or 2.7 percent, to $5.67 in morning trading after rising as high as $6 earlier in the session.

The stock jumped in late November after Orexigen had said it intended to resubmit Contrave to the FDA in the next few weeks. The shares were up about 11 percent for 2013 as of Tuesday's close.

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Orexigen Therapeutics Inc.

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3344 North Torrey Pines Ct. Ste., 200
La Jolla, CA 92037