FDA Approves Orexigen's Diet Drug Contrave

The U.S. Food and Drug Administration said it approved Orexigen Therapeutics Inc.'s weight-loss treatment Contrave, the third such drug to receive the agency's approval in recent years.

Contrave has been approved to treat chronic weight management, in conjunction with a reduced-calorie diet and physical activity, the FDA said Wednesday on its website.

The companies said in a separate news release that they expect to launch Contrave this fall but didn't provide any pricing information.

Weight-loss treatments Qsymia, sold by Vivus Inc., and Belviq, marketed jointly by Arena Pharmaceuticals Inc. and Eisai Co., received FDA approval in 2012. Sales of those obesity drugs have largely disappointed investors amid questions about their long-term efficacy and safety.

U.S.-based Orexigen signed a partnership in 2010 with Takeda Pharmaceutical Co. of Japan to sell Contrave in North America.

In 2011, the FDA had rejected the drug despite an advisory panel of physicians recommending the treatment's approval. Orexigen subsequently suspended development of the drug but eventually began a new trial.

The biopharmaceutical company last year said it would again seek regulatory approval for Contrave after interim study results showed that the drug didn't dramatically increase patients' risk of suffering a heart attack or other adverse events.

As part of the FDA's approval, Takeda and Orexigen agreed to do several post-marketing studies, including evaluating Contrave's long-term cardiovascular impact as well as its safety and efficacy in obese pediatric patients.

Orexigen also has submitted an application for Contrave's approval in Europe, with a decision there possible later this year.

Contrave is a combination of two drugs already on the market: addiction-treating naltrexone and the antidepressant bupropion, commonly known by the brand name Wellbutrin.

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