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TorreyPines Initiates Pain Drug Trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

TorreyPines Therapeutics initiated a Phase I trial for NGX426, an oral therapy intended to treat migraine and chronic pain conditions such as neuropathic pain. The double-blind, placebo-controlled, single ascending dose study, will evaluate the safety, tolerability and pharmacokinetics of NGX426 in 30 healthy volunteers. NGX426 is a prodrug of tezampanel, the company’s parenteral product candidate in development for migraine.

Tezampanel and NGX426 are AK receptor antagonists that potentially offer a non-opioid, non-vascular approach to the management of migraine and other persistent pain states. Preclinical studies have shown that, following oral administration, NGX426 is rapidly converted to tezampanel. Previous results of a Phase I trial with tezampanel showed that the compound was well tolerated when delivered subcutaneously to healthy adult males at single doses of as much as 100 mg. Five Phase IIa, studies have demonstrated that tezampanel was more effective than placebo in relieving pain symptoms across multiple pain models including migraine. The company is planning to initiate a Phase IIb trial with tezampanel, administered subcutaneously, for the treatment of migraine this year.

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