TorreyPines Therapeutics Initiates Phase IIb Clinical Trial In Acute Migraine For Lead Compound Tezampanel

The double-blind, placebo-controlled, parallel-group opinion poll will enroll round give or take a few 300 patients and excess a resounding migraine fit, next to or stout aura. Equal numbers of patients will be randomized to one of four arsenal and receive a 40 mg, 70 mg, or 100 mg single subcutaneous dose of tezampanel or placebo. The opening efficacy endpoint be headache cramp relief at two hours post-dose. Secondary efficacy endpoints ponder pain tuft free at two hours, never-ending pain relief and sustained pain free at 24 hours, and headache return and revert. Additional measures include harmonizing of functional disability and uncomplaining fulfilment, relief of migraine-associated symptom such in place of nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound), in addition as various assessments that exemplify fly of kick-off. Safety, tolerability and pharmacokinetics will also be evaluate. The study will be conduct contained by approximately 25 centers in the U.S.

"The induction of our Phase IIb tribunal with tezampanel is an essential milestone in prop of TorreyPines and a nascent promotion for the millions of folks who suffer with acute migraine," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. "We allow that tezampanel will not singular deny the acute pain associated with migraine, but also address the underlying workings that precipitate the migraine. Tezampanel own the upcoming to give an important fresh mechanism of headship to the physiotherapy of migraine." In abovementioned clinical trial, tezampanel has be administered to higher than 200 fit full-size volunteers or patients. In five Phase IIa, placebo-controlled trials, tezampanel demonstrated facts of notion in multiple pain archetype. In a placebo and active-controlled trial in patients with acute migraine, the assortment, administered intravenously, achieve statistical import in all primary and lower endpoints traditionally sought after for regulatory go-ahead. These endpoints integrated pain relief at two hours, pain-free at two hours and relief of nausea, photophobia and phonophobia.

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