Are Some Diet Drugs Rising From the Ashes? - Wall Street Journal (blog)

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Is obesity-drug development the regulatory graveyard that it's now widely thought to be?

The last year hasn't been kind to makers of potential obesity treatments. The FDA has rejected one after another. Among those getting the Heisman were Qnexa from Vivus, lorcaserin from Arena and Contrave from Orexigen and Japan's Takeda.

Under FDA pressure, Abbott last year removed its weight-loss drug Meridia from the market.

The regulator's concern has been balancing what it describes as relatively limited weight-loss effects with the proposed drugs' potential side effects, namely heart attacks and strokes. The FDA has a long memory of troubles with previous diet drugs, such as the infamous fen-phen.

Perhaps there's a way forward for at least some of the drugs, however.

Orexigen said late yesterday that it planned to resume development of Contrave after meetings with the FDA showed a path to approval in 2014. The San Diego company will conduct a new clinical study assessing whether Contrave contributed to a higher risk of heart attacks.

The news has sent Orexigen shares soaring today, helping the stock make up a big chunk of the more than 80% in value lost so far this year.

Likewise, Vivus shares jumped after the company said last week that it would re-submit its application for Qnexa. Arena said in August it plans to submit a response to the FDA by the end of the year.

Image: iStockphoto

21 Sep, 2011

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