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Apr 4, 2012

2-to-1 Majority of Respondents to a GEN Poll See Smooth Sailing Ahead for Vivus' Obesity Therapy

  • By a greater than 2-to-1 majority, GEN readers predict FDA will approve without further clinical investigation the weight-loss drug Qnexa, which faces an April 17 deadline for action by the agency. Most respondents (65.3%) predicted FDA will approve Qnexa, while 27.2% anticipate an FDA rejection, and 7.5% were undecided.

    Qnexa’s developer Vivus received welcome news on February 22 when an FDA advisory committee voted 20 to 2 in favor of the drug, concluding that its weight loss benefits outweighed its potential risks. That’s a change from 2010, when the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-6 against FDA approving the drug due to side effects that included serious birth defects and heart problems. Since then, Vivus conducted a one-year clinical trial with new data, while only 12 holdovers from the 2010 panel remain on the current advisory committee. FDA is expected to assuage lingering concerns by asking for a post-approval cardiovascular outcomes study.



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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

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