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Thread: King's investigational new drug application for neuropathic pain is approved

  1. #1

    King's investigational new drug application for neuropathic pain is approved

    King's investigational new drug application for neuropathic pain is approved
    28 Oct 2003

    The FDA has approved King Pharmaceutical's [KG] investigational new drug application for T-62, a treatment for neuropathic pain. A phase I trial to determine the safety of T-62, a new chemical entity, is now planned to begin during the fourth quarter of 2003.The trial represents an important step forward in providing patients who suffer from neuropathic pain with the first orally administered product in a new class of investigational agents indicated for the treatment of this prevalent condition.

    Neuropathic pain refers to pain initially caused by injuries to the nerve fibers. Symptoms described often include intense burning, shooting or stabbing pain and a heightened sense of touch, for which traditional pain relievers are not effective. Typical examples of neuropathic pain include diabetic neuropathy, post-herpetic neuralgia, and pain associated with spinal cord injury.

    The initial phase I trial of T-62 will be a single-center, randomized double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of escalating single oral doses of this new chemical entity in healthy adult subjects.


  2. #2
    Senior Member mike's Avatar
    Join Date
    Jul 2001
    Florence, Kentucky
    Thought this might be of some interest. I contacted Kings Pharmaceuticals to determine the status of trials for this new drug. The following is the reply I received:

    Thank you for your interest in our T62 program. Currently this compound is
    in very early stages of development and is not yet recruiting patients into
    clinical trials. Once recruitment of patients begins, King Pharmaceuticals
    may post clinical trials on the FDA's website. This
    web site is intended to make known clinical trial opportunities to both the
    general public and health care providers. The information that is provided
    on this website, in part, provides a list of participating physicians from
    which you can determine if one exists in your area.


    Tim Warneke, MS
    Director, Clinical Operations
    King Pharmaceuticals, Research & Development
    4000 CentreGreen Way
    Suite 300
    Cary, NC 27513


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