Orexigen Therapeutics Inc. shares jumped Monday after the drugmaker said it expects to resubmit its application for the potential weight-loss treatment Contrave to federal regulators in the next few weeks.
The La Jolla, Calif., company said Monday that the Food and Drug Administration could decide on Contrave’s approval by June.
Contrave is a pill that combines bupropion, the active ingredient in the antidepressant Wellbutrin, with the anti-addiction drug naltrexone. The FDA refused to approve the drug in February 2011. Since then the agency has approved the obesity drugs Qsymia from Vivus Inc. and Arena Pharmaceuticals Inc.’s Belviq, after initially rejecting both drugs
Orexigen said Monday that Contrave 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 no products on the market, and Contrave its lead candidate. Orexigen applied last month for marketing approval for the drug in Europe. It has licensed North American rights for Contrave to Japanese drugmaker Takeda Pharmaceuticals.
Shares of Orexigen jumped almost13 percent, or 73 cents, to $6.41 in morning trading Monday. The stock had risen 8 percent so far this year.