Associated Press (02/17/12) Perrone, Matthew
Previously rejected in Oct. 2010, Vivus' diet pill Qnexa is being resubmitted for approval from the FDA with additional follow-up information. Vivus, Arena Pharmaceuticals and Orexigen Therapeutics are competing to introduce the first prescription weight loss drug in over a decade, but all three have had their submitted drugs rejected during the past two years. The FDA has said that it is still concerns about two safety issues previously affecting Qnexa, birth defects in women who become pregnant while on the drug and potential heart problems. An FDA panel of experts will weigh in on the issues of birth defects, increased blood pressure, and higher heart rates; and then vote, though a final FDA decision is not expected until April. Qnexa combines the an anticonvulsant called topiramate, that induces feelings of satiation, and the amphetamine phentermine which is approved for short-term weight loss. Studies have indicated that Qnexa produced high levels of weight loss, on average the loss was over 10 percent of total body mass. The drug is linked to dangerous side effects, beyond birth defects which are more than doubled by topiramate, including memory lapses, heart palpitations and suicidal thoughts. Only Roche's Xenical is on the market, but as it only produces modest weight loss results, it is not widely used.

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