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The fallout continues for Transcept Pharmaceuticals (TSPT -7.6%) after the FDA's rejection of...

The fallout continues for Transcept Pharmaceuticals (TSPT -7.6%) after the FDA's rejection of its insomnia drug Intermezzo last week. The company announced plans over the weekend to slash its workforce by 45%, phasing out a number of "non-essential" positions in order to reduce operating expenses.
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  • mike711
    , contributor
    Comments (6) | Send Message
     
    It seems the FDA's rational for not approving Intermezzo subjects
    Transcept to a standard far higher than it required in approving
    Ambien. Both Intermezzo and Ambien use the same agent,
    Zolpidem, to induce sleep. The Transcept driving study showed
    if Intermezzo was taken 3 hours before awakening and Ambien
    was taken 7 hours before awakening (both cases 1 hour less
    than intended usage), Ambien driving test results produced more
    erratic driving. The FDA has stated, in its Complete Response
    Letter, that it is worried that a small percentage of individuals
    will have higher blood levels of Zolpidem, due to genetics, and
    therefore might constitue a driving risk if taking Intermezzo. The
    FDA has asked Transcept to figure out how to resolve this
    issue in order to obtain approval. No such requirement was
    made for the approval of Ambien. If the FDA believes that the
    hazard caused by taking Intermezzo is so great that the drug
    should not be approved, then how can they allow this same
    hazard to exist with the already approved drug, Ambien? There
    are hazards associated with almost all approved drugs. Up
    till now, the FDA has determined that the individual using the
    drug is capable, with the proper drug labeling, of deciding how,
    when, and if to use the drug. Consumers should be outraged
    that a government organization has now decided that the
    public isn't capable of managing its medications. This added
    hurdle to FDA drug approval will significantly add to the cost
    drugs getting to market. No only will this cost burden fall on
    the public but vital drugs to save lives will be sitting in the
    pipeline much longer also.
    20 Jul 2011, 06:22 PM Reply Like
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