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TorreyPines' NGX426, an Oral AMPA/Kainate Receptor Antagonist, Meets Primary Endpoints in Reducing Capsaicin-Induced Pain in Healthy Subjects
Date:12/1/2008

LA JOLLA, Calif., Dec. 1 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that oral administration of NGX426, an AMPA/kainate-type glutamate receptor antagonist, demonstrated a statistically significant reduction in spontaneous pain, hyperalgesia (abnormally increased pain state) and allodynia (pain resulting from normally non-painful stimuli to the skin) compared to placebo following intradermal injections of capsaicin in a human experimental model of cutaneous pain, hyperalgesia and allodynia.

"Human experimental models of pain are emerging as tools to predict efficacy of novel analgesics in early clinical trials," said principal investigator Mark Wallace, M.D., Professor of Clinical Anesthesiology and Program Director, University of California San Diego Center for Pain Medicine. "The results of NGX426 in this study are exciting and suggest that this drug will be effective in clinical pain states. These study results should provide guidance in the development of Phase II clinical trials."

The single-center, in-clinic, randomized, double-blinded study enrolled a total of 18 healthy male subjects. Using a three-period cross-over design, subjects received two intradermal injections of capsaicin at 30 minutes and 120 minutes after administration of a single, oral dose of 90 mg or 150 mg of NGX426, or placebo. Pain assessments were determined at specified intervals after each injection of capsaicin and measured by visual analog scale.

The 90 mg and 150 mg doses of NGX426 demonstrated analgesic effect on the primary endpoints. The 150 mg dose was statistically significant compared to placebo on all three measures: reduction in spontaneous pain, hyperalgesia and allodynia. The 90 mg dose also showed statistical significance on reduction of hyperalgesia and allodynia and t
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SOURCE TorreyPines Therapeutics, Inc.
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