Orexigen will try to do what competitors Arena Pharmaceuticals (ARNA) and Vivus (VVUS) failed to do earlier this year -- convince a group of outside experts that the company has a weight-loss drug that is both effective and safe for the millions of obese Americans who can't seem to shed the pounds with diet and exercise alone.
Last Friday, an FDA review concluded that Contrave helped patients lose weight but regulators also raised concerns about the drug's safety, most notably a small increase in heart rate and blood pressure.The FDA advisory panel will be asked to assess Contrave's efficacy and safety and vote on whether to recommend the drug's approval. An approval decision by FDA is expected on Jan. 31, 2011. The Contrave advisory panel comes not only after FDA rejected competing weight-loss drugs from Vivus and Arena, but also a few days after a different FDA panel voted to recommend the expanded surgical use of Allergan's (AGN) stomach-shrinking lap band. Orexigen shares will be halted all day Tuesday during the FDA advisory panel for Contrave. The stock closed Monday at $4.76. --Written by Adam Feuerstein in Boston.
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