Development of Gabapentin for Neuropathic Pain

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Lakhbir Singh and Mark Field performed initial studies of gabapentin for use as an analgesic in animal models in 1992-1993 at the Parke-Davis Cambridge (UK) Research Centre. They found that gabapentin was active in several rat models of antihyperalgesic action (formalin test, carrageenan test),37,38 although at rather high dosages. Gary Bennett obtained a sample of gabapentin in 1993, and tested it in his model of neuropathic pain from sciatic nerve ligation in rats.39 These results from animal models were presented by Bennett at a national meeting in 1994, and at about the same time, the first case reports of gabapentin use for neuropathic pain appeared in the literature.40,41 Subsequently, a large number of investigators found gabapentin to be active in animal models of pain states14,38,42-61 and also in several clinical studies.62-65

In 1995 and 1996, Parke-Davis began two large placebo-controlled parallel group studies of gabapentin for treating neuropathic pain. Clinical trials for diabetic peripheral neuropathy were supervised by Elizabeth Garofalo (Parke-Davis, Ann Arbor), and postherpetic neuralgia studies by Leslie Magnus-Miller (Parke-Davis, Morris Plains). Both studies were done with virtually identical protocols. These studies were both resoundingly positive in comparison to placebo treatment, and the results were published side by side in the Journal of the American Medical Association in 1998.66,67

In 1998 and 1999, based on the published Journal of the American Medical Association clinical studies, the first regulatory approvals were obtained for gabapentin to treat neuropathic pain in Asia and Latin America, then later in Europe. In early 2001, it was decided to submit a supplementary NDA (sNDA) application in the US with gabapentin for neuropathic pain, based upon the recently obtained clinical data. The submission was completed in August 2001 and the FDA approved the sNDA and provided revised labeling for gabapentin for treatment of postherpetic neuralgia on May 24, 2002. The commercial launch of gabapentin for postherpetic neuralgia was in August of 2002.

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