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www.fdanews.com/articles/61495-torreypines-initiates-trial-of-ngx426-for-migraine-pain

TORREYPINES INITIATES TRIAL OF NGX426 FOR MIGRAINE PAIN

August 7, 2006

TorreyPines Therapeutics has initiated a Phase I trial of NGX426 (tezampanel), an oral therapy that is intended to treat migraine and chronic pain conditions such as neuropathic pain. Designed as a double-blind, placebo-controlled, single ascending-dose study, the trial will evaluate the safety, tolerability and pharmacokinetics of NGX426 in 30 healthy adult male and female volunteers at one center in the U.S.

Tezampanel and NGX426 are AMPA/kainate receptor antagonists that potentially offer a non-opioid, non-vascular approach to the management of migraine and other persistent pain states. In May, TorreyPines reported results of a Phase I trial with tezampanel that showed the compound was well-tolerated when delivered subcutaneously to healthy adult males at single doses up to and including 100 mg. Five Phase IIa, double-blind, placebo-controlled studies have demonstrated that tezampanel, administered intravenously, was more effective than placebo in relieving pain symptoms across multiple pain models including migraine.