antiquity
10-28-2003, 09:23 AM
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.
Source (http://www.datamonitor.com/~36a9812221be4502a3d935cd67a618b9~/all/news/product.asp?pid=284BC31B-93EC-4F52-A8D3-15B111A7F4F2)
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.
Source (http://www.datamonitor.com/~36a9812221be4502a3d935cd67a618b9~/all/news/product.asp?pid=284BC31B-93EC-4F52-A8D3-15B111A7F4F2)