Tezampanel Meets Primary Endpoint in Phase IIb Clinical Trial in Acute Migrain...( - Company Plans to Move Comp...),Health

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LA JOLLA, Calif., Oct. 22 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that tezampanel met the primary endpoint in a 306-patient, Phase IIb clinical trial for the treatment of a single, acute migraine attack. In the study, which evaluated tezampanel administered subcutaneously, the 40 mg dose demonstrated statistically significant improvement on headache pain response at two hours post-dose compared to placebo (78.2 percent versus 58.7 percent; p=0.033, corrected for multiplicity) and the response was sustained through 24 hours post-dose. Although not powered to demonstrate statistical significance, improvement in key secondary measures at 40 mg, nevertheless, were either statistically significant (p<0.050) or trending (p<0.100) when compared to placebo and corroborated the results for the primary endpoint of the study. These key secondary measures included nausea or vomiting, photophobia, a sum of pain intensity scores at three and four hours post-dose, sustained headache response at 24 hours, functional disability and a composite score of core migraine symptoms at two and four hours post-dose that included measures of headache severity, nausea, vomiting, photophobia, phonophobia and functional disability. Two other doses of tezampanel, 70 mg and 100 mg, were evaluated and also demonstrated effects across various pain measures although neither dose reached statistical significance on the primary endpoint. The company intends to submit the data from this trial to the U. S. Food and Drug Administration (FDA) in order to initiate a Phas
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