Orexigen's Contrave Approved by FDA

The U.S. Food and Drug Administration has approved a weight-loss drug developed by La Jolla-based Orexigen Therapeutics Inc.

Orexigen is partnered with Japanese pharmaceutical giant, Takeda Pharmaceutical Company Ltd., to manage marketing and sales of the new drug, Contrave. Takeda has assigned 900 sales representatives to the launch.

Wells Fargo analyst Matthew Andrews expects Contrave’s U.S. sales to eclipse that of competing weight-loss drugs, Belviq and Qsymia,

Belviq was developed by San Diego-based Arena Pharmaceuticals Inc. and Qsymia was made by Vivus Inc. based in Mountain View. Both competing drugs were approved in 2012.

Contrave sales are expected to be about $200 million in 2016, slightly higher than Belviq’s $180 million and well ahead of Qsymia’s $150 million, said Andrews, who covers all three companies.

Arena reported Belviq sales of $5.7 million in 2013, with $5.3 million of that attributable to its partner Eisai Co. Qsymia’s sales were$23.7 million.

Orexigen’s new drug is a combination of bupropion, the active ingredient in the antidepressant Wellbutrin, and naltrexone, an opioid blocker used to help stop alcohol and opioid addiction.

In June, the FDA had delayed its decision on the drug by three months due to concerns about possibly inadequate warnings on the packaging. Orexigen responded with a 47 page long label topped by a black-box warning alerting doctors about the risk of suicidal thought and other psychiatric adverse events related to the antidepressant bupropion component of the combination therapy.

After the announcement of FDA approval was made Wednesday night, Orexigen shares fell 8 percent to $5.43. Shares closed Sept. 11 at $5.28 on the Nasdaq under the ticker symbol OREX.

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